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American Preclinical Services

Minneapolis, Minnesota, US

APS is a State of the Art, AAALAC and ISO17025 accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN specializing in medical device and pharmaceutical testing.

By utilizing our catalogue of services, which includes regulatory consulting, ISO10993 biocompatibility testing, analytical testing, interventional, surgical, toxicology, pharmacology, pain, physician training, bioskills, animal model development, and complete pathology services, you’ll be able to develop and conduct a powerful preclinical program.

Whether your company is a startup or an established industry leader, our experienced scientific staff has the expertise to meet your research needs and timelines. Pilot and screening evaluations, feasibility and efficacy testing or ultimately GLP safety studies of the finished product, you will have industry experts to rely on every step of the way.

We... Show more »

APS is a State of the Art, AAALAC and ISO17025 accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN specializing in medical device and pharmaceutical testing.

By utilizing our catalogue of services, which includes regulatory consulting, ISO10993 biocompatibility testing, analytical testing, interventional, surgical, toxicology, pharmacology, pain, physician training, bioskills, animal model development, and complete pathology services, you’ll be able to develop and conduct a powerful preclinical program.

Whether your company is a startup or an established industry leader, our experienced scientific staff has the expertise to meet your research needs and timelines. Pilot and screening evaluations, feasibility and efficacy testing or ultimately GLP safety studies of the finished product, you will have industry experts to rely on every step of the way.

We strive to deliver comprehensive, yet rapid service with the understanding that in product development, the only constant is change. We’ve tailored our processes, capacity, and customer service to keep up with today’s fast paced business cycles. APS will go from a quote to a ready to implement study design with your time lines in full focus.

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APS Analytical Services

Minneapolis Minnesota
No Reviews Available

APS has added a 2000 ft² analytical laboratory equipped with state-of-the art instrumentations and exceptional personnel expertise providing GLP compliant analytical supports. The laboratory is equipped to provide a full range of analytical services to facilitate integration and... Show more »

APS has added a 2000 ft² analytical laboratory equipped with state-of-the art instrumentations and exceptional personnel expertise providing GLP compliant analytical supports. The laboratory is equipped to provide a full range of analytical services to facilitate integration and overlapping of various study components such as pharmacokinetic, toxicology, biocompatibility, quality control, stability studies, purity and impurity characterization and profiling, leachables and extractable from container closure, implantable medical devices, drug carriers, drug delivery systems and packaging materials.

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APS Biocompatibility Testing

Minneapolis Minnesota
No Reviews Available

American Preclinical Services offers a full biocompatibility testing program. Here at APS, we take the time to understand the specifics of your medical devices and we take a clinically relevant approach to designing and implementing your panel of biocompatibility assays. At APS you... Show more »

American Preclinical Services offers a full biocompatibility testing program. Here at APS, we take the time to understand the specifics of your medical devices and we take a clinically relevant approach to designing and implementing your panel of biocompatibility assays. At APS you benefit from:

  • A Team of professionals that understand the clinically indicated use of medical devices and assist in defining the appropriate biocompatibility testing required for your device and developing any necessary custom techniques to allow for reliable testing of even the more complex medical devices.
  • A variety of custom extractions to meet your device needs.
  • A focus on minimizing the number of devices used through extraction and test assay planning.
  • Biocompatibility testing according to ISO, USP, and JMHLW guidelines.
  • USDA-registered facilities that are accredited by ISO 17025 and the American Association for the Accreditation of Laboratory Animal Care (AAALAC).

Standard & Custom Protocols

APS offers both standard (ISO10993, USP <87>, USP <88> & JMHLW) and custom biocompatibility testing protocols for material and component evaluations, in-vivo and in-vitro testing.

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APS Interventional and Surgical Research

Minneapolis Minnesota
Order Completed

American Preclinical Services specializes in medical device and combination product research. Within our one-of-a-kind research facility, highly skilled interventionalists, surgeons and clinicians use the latest, most powerful tools and techniques to perform the research you... Show more »

American Preclinical Services specializes in medical device and combination product research. Within our one-of-a-kind research facility, highly skilled interventionalists, surgeons and clinicians use the latest, most powerful tools and techniques to perform the research you require. Their in depth experience across a wide variety of devices and procedures assures your project is performed in a precise, professional and timely manner.

Acute and Chronic, feasibility to GLP safety Medical Device Studies

On your behalf, APS can perform a full range of studies for medical devices. Our study designs have been used for comparative trials, 510(k) submissions, long-term safety studies for novel PMA devices, complex safety and pharmacokinetics trials for combination devices, and more.

Every step of the way, the APS team of scientists, study directors, technicians, and quality professionals are standing by to assist you.

We offer a world class facility for performing complex implant and treatment procedures that meet the demands of today’s medical devices. Our operating suites have the latest medical imaging equipment. The combination of advanced imaging systems and technical expertise will help bridge preclinical trials into human clinical trials.
The unique campus at APS gives you preclinical services for any medical device. We are able to source test systems, develop preclinical models, perform implant and treatment procedures, collect detailed study data, and synthesize a comprehensive study report. All these areas are fully supported by our ISO 17025 accredited and GLP compliant quality systems. You can depend on APS to provide you a well designed, well executed study culminating in reliable data and quality final reports.

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APS Pain Research

Minneapolis Minnesota
Orders Completed
100% Positive

APS offers a comprehensive portfolio of rodent pain models designed for the assessment of novel analgesic therapies. We have compiled a highly skilled team of experts in the field of behavioral pharmacology, with experience in the pharmaceutical, medical device, and CRO... Show more »

APS offers a comprehensive portfolio of rodent pain models designed for the assessment of novel analgesic therapies. We have compiled a highly skilled team of experts in the field of behavioral pharmacology, with experience in the pharmaceutical, medical device, and CRO industries.

As we strive to be your partner in your discovery research efforts, we have built our offerings to encompass models and assays that cover a range of discovery needs. Whether you need to screen a large number of compounds quickly or need to fully characterize a single compound, APS has the capabilities and experience to help you meet your goals.

As experienced pain researchers, we recognize that pain can manifest itself in multiple and diverse ways: hypersensitivity, use-related pain behaviors, and pain-suppressed behaviors to name a few. As such, we have established multiple ways to assess pain-related behaviors and we are constantly striving to add to and refine our offerings.

Our services include the following endpoints:

  • Mechanical Allodynia
  • Mechanical Hyperalgesia
  • Thermal Hyperalgesia
  • Weight Bearing
  • Grip Strenth
  • Joint Compresion
  • Spontaneous Flinching
  • Visceromotor Response (EMG)
  • Acute Nociception
  • Intestinal Transit
« Show less
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APS Pathology Services

Minneapolis Minnesota
No Reviews Available

Pathology is the gold standard for the evaluation of medical device performance and safety designed for high volume and rapid throughput to meet and exceed all of your tissue and device collection requirements. APS has extensive histopathology services for preclinical research... Show more »

Pathology is the gold standard for the evaluation of medical device performance and safety designed for high volume and rapid throughput to meet and exceed all of your tissue and device collection requirements. APS has extensive histopathology services for preclinical research studies. We also offer a full set of services for studies performed at outside labs, as well as pathologist consulting services conducted within a comfortable working environment.

The APS pathology department operates a fully equipped, 5,000 square foot, histopathology and SEM laboratory in the main facility. APS pathology lab is operated by board certified histotechnicians and has advanced equipment for the precise sectioning of all medical devices, using paraffin, plastic thin microtomy, plastic EXAKT ground sectioning, and SEM techniques.

Our dedicated necropsy labs feature down draft tables, as well as gravity and static pressure perfusion systems to ensure that, once harvested, organs are completely fixed prior to histoprocessing. APS pathology staff are also highly skilled at intricate dissections necessary for today's complex tissue treatments and device implants. We take tissue and device harvest seriously.

APS has both board certified veterinary pathologists and MD, PhD pathologists who oversee gross necropsies, interpret histopathology slides and write reports evaluating the safety of products. Our pathology services technicians possess college degrees, histotechnology board certifications and have many years of hands-on experience.

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APS Toxicology and Pharmacology

Minneapolis Minnesota
No Reviews Available

American Preclinical Services offers a variety of general toxicology, pharmacokinetics (PK), toxicokinetics (TK), absorption/distribution/metabolism/excretion (ADME), and safety pharmacology studies in both rodents and non-rodent animal models. Our facility offers many key features... Show more »

American Preclinical Services offers a variety of general toxicology, pharmacokinetics (PK), toxicokinetics (TK), absorption/distribution/metabolism/excretion (ADME), and safety pharmacology studies in both rodents and non-rodent animal models. Our facility offers many key features such as independently ventilated rodent cages, digital monitoring of animal rooms, microchip identification, and a high capacity for study starts to help meet your timelines.

APS is licensed by Minnesota Department of Health (MDH) for the use of a wide range of radioisotopes such as Calcium-45, Carbon-14, Hydrogen-3, Iodine-125, Iodine-131, and Phosphorus-32 commonly utilized in synthesis and in-vivo tracking of drugs and biologicals. We have dedicated in-vitro laboratory space, animal procedure rooms and housing for isotope use for a wide range of PK and ADME studies.

Routes of Dosing/Administration

  • Intravenous/Intraarterial
  • Intracardiac
  • Oral
  • Topical/Transdermal
  • Intramuscular/Subcutaneous

Types of active materials Dosed

  • Low Molecular Weight Drugs
  • Peptides
  • Proteins/Biologicals
  • Complex Extracellular matrix
  • Cellular Therapy
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APS Regulatory Services

Minneapolis Minnesota
No Reviews Available

APS offers comprehensive global regulatory consulting services for the medical device industry. APS Regulatory Services will partner with your organization and support you through the regulatory process in the United States and major international markets by developing a plan to... Show more »

APS offers comprehensive global regulatory consulting services for the medical device industry. APS Regulatory Services will partner with your organization and support you through the regulatory process in the United States and major international markets by developing a plan to achieve timely medical device approvals and registrations. Our capabilities include:

Strategic regulatory planning

  • Pre - Clinical Studies Strategy and Testing
  • Pre-market approval application (PMA)
  • Investigational device exemption (IDE)
  • Pre-market notification (510k)
  • Humanitarian device exemption (HDE)
  • Humanitarian device (HUD)
  • Expedited Access Pathway (EAP) for medical devices normally subject to Premarket Approval (PMA) or De novo registration
  • FDA Device Registration and Listing
  • Device master files submissions
  • U.S Agent
  • Implementation of FDA eSubmitter electronic Medical device reporting (eMDR) establishment and implementation
  • Product development protocol (PDP)
  • Labeling Review
  • Interpretation of standards and guidelines
  • Preparation and representation at FDA advisory panels and regulatory agency meetings
  • Establishment Registration and device listings
  • Import/export certificates and registrations

Strategic Approach to Regulatory Planning

Strategic regulatory plan involves addressing many elements ranging from the relatively simple to the complex.

  • Device classifications and negotiation of device classification designation with regulatory agencies
  • Defining Intended use and indications for the medical devices
  • Defining Key product claims based on scientific evidence
  • Establishing possible predicate devices
  • Defining country specific regulatory pathways and possible regulatory risks
  • Defining applicable regulatory guidance documents
  • Interpreting technical standards and directives
  • Negotiation of device data development plans with regulatory agencies
  • Preclinical studies planning and negotiation with regulatory agencies
  • Establishing and reviewing labeling requirements and labels
  • Submission of device pre-market applications for approval
  • Establishment registration (for manufacturing sites) and device listings
  • Defining and supporting import/export requirements
  • Managing post approval modifications to product and manufacturing process

APS Regulatory Service consultants have successful attained approvals from major global regulatory agencies including but not limited to:

  • Food and Drug Administration (FDA) (United States )
  • European Union (CE mark)
  • Therapeutic Products Programme (TPP) (Canada)
  • Medicines and Healthcare Products Regulatory Agency (MHRA) (United Kingdom)
  • Ministry of Health, Labour and Welfare (Japan)
  • Therapeutic Goods Administration (TGA) (Australia)
  • State Food and Drug Administration (SFDA) (China)
  • Ministry of Health and Family Welfare (India)
  • Agência Nacional de Vigilância Sanitária (ANVISA) (Brazil)
  • COFEPRIS, Mexican division of the Ministry of Health (Secretaría de Salud) (Mexico)
  • National Food and Drug Surveillance Institute (INVIMA) (Colombia)
  • Ministry of Health (Costa Rica)
  • Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) (Peru)
  • Asociación Nacional de Medicamentos, Alimentos y Tecnología (ANMAT) (Argentina)
  • Oficina de Inscripción Control de Equipos Médicos y Para Médicos (OICEM) (Venezuela)
  • National Institute of Hygiene and Tropical Medicine (ECUADOR)
  • Ministerio de Salud (URUGUAY)
  • Directorate of Medicines and Health Products (DIRMED) (El-Salvador)
  • Health Registration Law by the Dirección General de Servicios de Salud (GUATEMALA)
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American Preclinical Services has not listed any services.

Ask A Question Find what you're looking for? If not, you can ask this lab a question:
Pulmonary Hypertension Animal Models
Price on request
Request a quote for more information about this service.
Medical Device Testing
Price on request

APS is experienced in the following interventional models and device product testing:
Cardiovascular
Renal Denervation
Coronary Vascular Drug Eluting Stents and Scaffolds (DES)
Coronary Vascular Bare Metal Stents (BMS)
Peripheral Vascular Drug Eluting Stents and Scaffolds (DES)
Peripheral Vascular Bare Metal Stents... Show more »

APS is experienced in the following interventional models and device product testing:
Cardiovascular
Renal Denervation
Coronary Vascular Drug Eluting Stents and Scaffolds (DES)
Coronary Vascular Bare Metal Stents (BMS)
Peripheral Vascular Drug Eluting Stents and Scaffolds (DES)
Peripheral Vascular Bare Metal Stents (BMS)
Drug Coated Balloons (DCB / DEB)
Transcatheter Valve Replacement (TAVI, TAVR)
POBA Balloons
Aortic Annuloplasty Balloons
Guide Wires
Guide Catheters
Trans-septal Catheters
Introducer Sheaths
Septal Defect Closure (ASD, PFO, PMVSD)
Atherectomy
Thrombectomy
Embolic Protection
Vascular Closure
Abdominal Aortic Aneurysm (AAA)
Left Atrial Appendage Occlusion
Endovascular Grafts
Patent ductus Arteriosus Closure
Perivalvular Leak Occlusion
Embolic Beads
Chronic Total Occlusion / Total Partial Occlusion Crossing Wires
Telemetry
Cell and Gene Therapy
Myocardial Infarction Models
Vascular Stimulation
Electophysiology
Cardiac Ablation
Cardiac Rhythm Management
Cardiac Leads
Pulmonary Vein Ablation
EP Recording and Mapping
Gastrointestinal
Obesity Devices
Biliary Catheter
Neuromodulation
Epidural leads
Carotid Sinus Stimulation
Pulmonary
Lung denervation
Lung Volume Reduction
Lung Biopsy
Drug Eluting Stents and Scaffolds (DES)
Bare Metal Stents and Scaffolds
Tracheal Stent
Urogenital
Kidney Cellular Regeneration
Prostate Ablation
Uterine Ablation

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Genetic Disorder Animal Models
Price on request

Watanabe Rabbits

APS has an active breeding colony of Watanabe Heritable Hyperlipidemic (WHHL) rabbits. WHHL rabbits have a genetic predisposition to hypercholesterolemia due to a reduced expression of low-density lipoprotein (LDL) receptors. WHHL rabbits frequently manifest vascular lesions and atherosclerotic disease with... Show more »

Watanabe Rabbits

APS has an active breeding colony of Watanabe Heritable Hyperlipidemic (WHHL) rabbits. WHHL rabbits have a genetic predisposition to hypercholesterolemia due to a reduced expression of low-density lipoprotein (LDL) receptors. WHHL rabbits frequently manifest vascular lesions and atherosclerotic disease with typical total cholesterol levels observed at the >600 mg/dL range. These conditions mimic human disease endpoints similar to those observed in coronary and peripheral artery disease. WHHL rabbit models have been frequently used to study hypercholesterolemia and atherosclerosis, and have aided in the development of medical devices and pharmacologic agents used in the treatment of these conditions.

Ossabaw swine

APS has extensive experience with studies using Ossabaw swine, which is a sound model for assessing treatments for hypertension and metabolic syndrome. Ossabaw swine express a phenotype for a propensity to obesity. Consumption of a high caloric diet causes these animals to manifest obesity, insulin resistance, impaired glucose tolerance, dyslipidemia, and hypertension. Ossabaw swine are also prone to atherosclerotic disease.

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Urogenital Animal Models
Price on request

APS works with all large and small research animal species with the exception of non-human primates. We have a wealth of experiences and capabilities that are brought to bear in helping clients answer their research questions and aid with study design. We regularly perform complex animal surgeries and model creations for... Show more »

APS works with all large and small research animal species with the exception of non-human primates. We have a wealth of experiences and capabilities that are brought to bear in helping clients answer their research questions and aid with study design. We regularly perform complex animal surgeries and model creations for establishing physiological or mechanical models of disease states. We are also experienced in sample collections and analysis of endpoints for biomarkers of disease.

Urogenital

  • Benign prostate hyperplasia (BPH)
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Orthopedic Models
Price on request

APS works with all large and small research animal species with the exception of non-human primates. We have a wealth of experiences and capabilities that are brought to bear in helping clients answer their research questions and aid with study design. We regularly perform complex animal surgeries and model creations for... Show more »

APS works with all large and small research animal species with the exception of non-human primates. We have a wealth of experiences and capabilities that are brought to bear in helping clients answer their research questions and aid with study design. We regularly perform complex animal surgeries and model creations for establishing physiological or mechanical models of disease states. We are also experienced in sample collections and analysis of endpoints for biomarkers of disease.

Orthopedic

  • Osteoarthritis
  • Bone Fracture
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Cardiovascular Animal Models
Price on request

APS works with all large and small research animal species with the exception of non-human primates. We have a wealth of experiences and capabilities that are brought to bear in helping clients answer their research questions and aid with study design. We regularly perform complex animal surgeries and model creations for... Show more »

APS works with all large and small research animal species with the exception of non-human primates. We have a wealth of experiences and capabilities that are brought to bear in helping clients answer their research questions and aid with study design. We regularly perform complex animal surgeries and model creations for establishing physiological or mechanical models of disease states. We are also experienced in sample collections and analysis of endpoints for biomarkers of disease.

Cardiovascular Models

  • Aneurysms
  • Myocardial Infarction
  • Ischemia Reperfusion
  • Hypertension
  • Chronic Total Occlusion (CTO) arterial lesions
  • Chronic Partial Occlusion (CPO) arterial lesions
  • In-stent Restenosis (ISR)
  • Cardiac Septal Defects
  • Venous Thrombosis (DVT)
  • Arteriovenous Fistula
  • Embolic protection
  • Endothelialization
  • Drug deposition
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Histology and Pathology Services
Price on request

Pathology is the gold standard for the evaluation of medical device performance and safety designed for high volume and rapid throughput to meet and exceed all of your tissue and device collection requirements. APS has extensive histopathology services for preclinical research studies. We also offer a full set of services for... Show more »

Pathology is the gold standard for the evaluation of medical device performance and safety designed for high volume and rapid throughput to meet and exceed all of your tissue and device collection requirements. APS has extensive histopathology services for preclinical research studies. We also offer a full set of services for studies performed at outside labs, as well as pathologist consulting services conducted within a comfortable working environment.

The APS pathology department operates a fully equipped, 5,000 square foot, histopathology and SEM laboratory in the main facility. APS pathology lab is operated by board certified histotechnicians and has advanced equipment for the precise sectioning of all medical devices, using paraffin, plastic thin microtomy, plastic EXAKT ground sectioning, and SEM techniques.

Our dedicated necropsy labs feature down draft tables, as well as gravity and static pressure perfusion systems to ensure that, once harvested, organs are completely fixed prior to histoprocessing. APS pathology staff are also highly skilled at intricate dissections necessary for today's complex tissue treatments and device implants. We take tissue and device harvest seriously.

APS has both board certified veterinary pathologists and MD, PhD pathologists who oversee gross necropsies, interpret histopathology slides and write reports evaluating the safety of products. Our pathology services technicians possess college degrees, histotechnology board certifications and have many years of hands-on experience.

Gross Pathology Capabilities

  • Post-mortem Exams
    • Large / Small Animal
    • Microdissection
    • In-situ perfusion fixation
    • Ex-vivo perfusion fixation
    • Fluorogram guided tissue harvesting
    • Pharmacokinetic sampling
    • TTC in-situ and ex-vivo staining
    • Evans blue staining
  • Imaging
    • Stereomicroscopy
    • High Resolution radiography (Faxitron)
    • OCT
    • IVUS
    • Fluoroscopy
    • Scanning Electron Microscope
    • Histomorphometry

Histopathology Capabilities

  • Embedding Capabilities:
    • Paraffin embedding
    • OCT medium
    • Spurr's Resin
    • MMA
  • Sectioning Techniques:
    • Microtomy
    • Cryosectioning
    • Plastic microtomy and EXAKT grinding
    • EXAKT grinding
  • Specialty Capabilities:
    • TTC in-situ staining
    • TTC ex-vivo staining
    • Resin and silicone Castings
    • Evan's Blue
  • Histology Stains:
    • Hemotoxylin and Eosin
    • Verhoeff Van Gieson
    • Luxol Fast Blue
    • PTAH and Carstairs (fibrin or muscle striations)
    • Gram
    • Von Kossa
    • Masson's Trichrome
    • Gomori Trichrome
    • Masson's Elastic Trichrome
    • Gomori Elastic Trichrome
    • Goldner's Trichrome
    • Movat's Pentachrome
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Custom Pain Animal Models
Price on request

APS offers a comprehensive portfolio of rodent pain models designed for the assessment of novel analgesic therapies. We have compiled a highly skilled team of experts in the field of behavioral pharmacology, with experience in the pharmaceutical, medical device, and CRO industries.

As we strive to be your partner in your... Show more »

APS offers a comprehensive portfolio of rodent pain models designed for the assessment of novel analgesic therapies. We have compiled a highly skilled team of experts in the field of behavioral pharmacology, with experience in the pharmaceutical, medical device, and CRO industries.

As we strive to be your partner in your discovery research efforts, we have built our offerings to encompass models and assays that cover a range of discovery needs. Whether you need to screen a large number of compounds quickly or need to fully characterize a single compound, APS has the capabilities and experience to help you meet your goals.

As experienced pain researchers, we recognize that pain can manifest itself in multiple and diverse ways: hypersensitivity, use-related pain behaviors, and pain-suppressed behaviors to name a few. As such, we have established multiple ways to assess pain-related behaviors and we are constantly striving to add to and refine our offerings.

Our services include the following endpoints:

  • Mechanical Allodynia
  • Mechanical Hyperalgesia
  • Thermal Hyperalgesia
  • Weight Bearing
  • Grip Strenth
  • Joint Compresion
  • Spontaneous Flinching
  • Visceromotor Response (EMG)
  • Acute Nociception
  • Intestinal Transit
« Show less
Pharmacology & Toxicology
Price on request

American Preclinical Services offers a variety of general toxicology, pharmacokinetics (PK), toxicokinetics (TK), absorption/distribution/metabolism/excretion (ADME), and safety pharmacology studies in both rodents and non-rodent animal models. Our facility offers many key features such as independently ventilated rodent cages,... Show more »

American Preclinical Services offers a variety of general toxicology, pharmacokinetics (PK), toxicokinetics (TK), absorption/distribution/metabolism/excretion (ADME), and safety pharmacology studies in both rodents and non-rodent animal models. Our facility offers many key features such as independently ventilated rodent cages, digital monitoring of animal rooms, microchip identification, and a high capacity for study starts to help meet your timelines.

APS is licensed by Minnesota Department of Health (MDH) for the use of a wide range of radioisotopes such as Calcium-45, Carbon-14, Hydrogen-3, Iodine-125, Iodine-131, and Phosphorus-32 commonly utilized in synthesis and in-vivo tracking of drugs and biologicals. We have dedicated in-vitro laboratory space, animal procedure rooms and housing for isotope use for a wide range of PK and ADME studies.

Routes of Dosing/Administration

  • Intravenous/Intraarterial
  • Intracardiac
  • Oral
  • Topical/Transdermal
  • Intramuscular/Subcutaneous

Types of active materials Dosed

  • Low Molecular Weight Drugs
  • Peptides
  • Proteins/Biologicals
  • Complex Extracellular matrix
  • Cellular Therapy
« Show less
ICP-MS
Inductively Coupled Plasma Mass Spectrometry
Price on request

ICP-MS is the premier technique for trace metals analysis in biological fluids, tissues, medical devices extracts, pharmaceutical products, etc. The system is based on Octopole Reaction System (ORS) technology operating in Helium collision mode to remove interferences, provide highest level of performance, extreme sensitivity and... Show more »

ICP-MS is the premier technique for trace metals analysis in biological fluids, tissues, medical devices extracts, pharmaceutical products, etc. The system is based on Octopole Reaction System (ORS) technology operating in Helium collision mode to remove interferences, provide highest level of performance, extreme sensitivity and a wide order of analytical dynamic range even in complex matrices. This unit allows for a powerful analysis while maintaining flexibility, automation and ease of use.

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GC-MS
Gas Chromatography Coupled Mass Spectrometry
Price on request

The GC is connected to an ISQTM Mass Spectrometer and Flame Ionization Detector (FID). The mass spectrometer has a mass range from 1.2-1100 u with industry leading low sensitivity for detection, quantification and identification of volatile and semi-volatile components based on their mass spectra and an extensive NIST Mass... Show more »

The GC is connected to an ISQTM Mass Spectrometer and Flame Ionization Detector (FID). The mass spectrometer has a mass range from 1.2-1100 u with industry leading low sensitivity for detection, quantification and identification of volatile and semi-volatile components based on their mass spectra and an extensive NIST Mass Spectral Library. The system is also equipped with static headspace analyzer and TriPlus RSH™ Autosampler for automated liquid and headspace injections.

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LC-MS
Liquid Chromatography-Coupled Mass Spectrometry
Price on request

A Dionex Ultimate 3000 UPLC connected to a Triple-Stage Quadrupole Mass Spectrometer (MSMS) and Diode Array Detector (DAD). It operates in electrospray positive (ESI+) and negative (ESI-). Excellent sensitivity, speed and dynamic range for method development, validation and routine sample analysis with the ability to separate and quantify the most complex and challenging samples.

A Dionex Ultimate 3000 UPLC connected to a Triple-Stage Quadrupole Mass Spectrometer (MSMS) and Diode Array Detector (DAD). It operates in electrospray positive (ESI+) and negative (ESI-). Excellent sensitivity, speed and dynamic range for method development, validation and routine sample analysis with the ability to separate and quantify the most complex and challenging samples.

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Biocompatibility Testing
Price on request

American Preclinical Services offers a full biocompatibility testing program. Here at APS, we take the time to understand the specifics of your medical devices and we take a clinically relevant approach to designing and implementing your panel of biocompatibility assays. At APS you benefit from:

American Preclinical Services offers a full biocompatibility testing program. Here at APS, we take the time to understand the specifics of your medical devices and we take a clinically relevant approach to designing and implementing your panel of biocompatibility assays. At APS you benefit from:

  • A Team of professionals that understand the clinically indicated use of medical devices and assist in defining the appropriate biocompatibility testing required for your device and developing any necessary custom techniques to allow for reliable testing of even the more complex medical devices.
  • A variety of custom extractions to meet your device needs.
  • A focus on minimizing the number of devices used through extraction and test assay planning.
  • Biocompatibility testing according to ISO, USP, and JMHLW guidelines.
  • USDA-registered facilities that are accredited by ISO 17025 and the American Association for the Accreditation of Laboratory Animal Care (AAALAC).
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Imaging & Spectroscopy
Price on request

Cutting edge imaging technology is at the heart of APS’ research processes, including diagnostic imaging for visualizing implants, diagnosing defects or disease, and documenting research outcomes.

APS acquires preclinical data in the same manner as done in the clinic. Thus, data can be used to bridge preclinical safety... Show more »

Cutting edge imaging technology is at the heart of APS’ research processes, including diagnostic imaging for visualizing implants, diagnosing defects or disease, and documenting research outcomes.

APS acquires preclinical data in the same manner as done in the clinic. Thus, data can be used to bridge preclinical safety endpoints to proposed clinical endpoints, permitting clinical labs to standardize measurements or obtain expert interpretations of results.

Diagnostic Imaging Modalities at APS

  • Fixed Fluoroscopy (Siemens AXIOM Artis and Zee digital cardiac cath labs)
  • Mobile Fluoroscopy (Siemens Avantic mobile c-arm)
  • 3D rotational fluoroscopy (Siemens Syngo®)
  • Dual Source Computed Tomography (Siemens Somatom® Definition)
  • Intravascular Ultrasound (IVUS) (Boston Scientific iLAB™)
  • Optical Coherence Tomography (OCT) (St. Jude Medical C7-XR™)
  • Intracardic (ICE) and Duplex Ultrasound (Siemens Cypress II and Sequoia)
  • Endoscopy (Olympus EVIS EXERA III)
  • EP Mapping (St. Jude Medical EnSite™ NavX™)
  • Faxitron (Digital MX20 and analog flat film)

Through trusted partners, APS is able to offer additional additional diagnostic imaging and analysis. All work performed with our partners is contracted and supervised by APS' personnel. These partnerships give APS access to a network of experts to assist in study design and interpretation of results.

Diagnostic Imaging Modalities through Partnerships

  • MRI (Siemens Avanto 1.5T, GE Signa HDx 3.0T)
  • MicroCT (NorthStar Imaging Systems)
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Regulatory Affairs Consulting
Price on request

APS offers comprehensive global regulatory consulting services for the medical device industry. APS Regulatory Services will partner with your organization and support you through the regulatory process in the United States and major international markets by developing a plan to achieve timely medical device approvals and... Show more »

APS offers comprehensive global regulatory consulting services for the medical device industry. APS Regulatory Services will partner with your organization and support you through the regulatory process in the United States and major international markets by developing a plan to achieve timely medical device approvals and registrations.

Our capabilities include:

  • Strategic regulatory planning
  • Pre - Clinical Studies Strategy and Testing
  • Pre-market approval application (PMA)
  • Investigational device exemption (IDE)
  • Pre-market notification (510k)
  • Humanitarian device exemption (HDE)
  • Humanitarian device (HUD)
  • Expedited Access Pathway (EAP) for medical devices normally subject to Premarket Approval (PMA) or De novo registration
  • FDA Device Registration and Listing
  • Device master files submissions
  • U.S Agent
  • Implementation of FDA eSubmitter electronic Medical device reporting (eMDR) establishment and implementation
  • Product development protocol (PDP)
  • Labeling Review
  • Interpretation of standards and guidelines
  • Preparation and representation at FDA advisory panels and regulatory agency meetings
  • Establishment Registration and device listings
  • Import/export certificates and registrations

Strategic Approach to Regulatory Planning

Strategic regulatory plan involves addressing many elements ranging from the relatively simple to the complex.

  • Device classifications and negotiation of device classification designation with regulatory agencies
  • Defining Intended use and indications for the medical devices
  • Defining Key product claims based on scientific evidence
  • Establishing possible predicate devices
  • Defining country specific regulatory pathways and possible regulatory risks
  • Defining applicable regulatory guidance documents
  • Interpreting technical standards and directives
  • Negotiation of device data development plans with regulatory agencies
  • Preclinical studies planning and negotiation with regulatory agencies
  • Establishing and reviewing labeling requirements and labels
  • Submission of device pre-market applications for approval
  • Establishment registration (for manufacturing sites) and device listings
  • Defining and supporting import/export requirements
  • Managing post approval modifications to product and manufacturing process

APS Regulatory Service consultants have successful attained approvals from major global regulatory agencies including but not limited to:

  • Food and Drug Administration (FDA) (United States )
  • European Union (CE mark)
  • Therapeutic Products Programme (TPP) (Canada)
  • Medicines and Healthcare Products Regulatory Agency (MHRA) (United Kingdom)
  • Ministry of Health, Labour and Welfare (Japan)
  • Therapeutic Goods Administration (TGA) (Australia)
  • State Food and Drug Administration (SFDA) (China)
  • Ministry of Health and Family Welfare (India)
  • Agência Nacional de Vigilância Sanitária (ANVISA) (Brazil)
  • COFEPRIS, Mexican division of the Ministry of Health (Secretaría de Salud) (Mexico)
  • National Food and Drug Surveillance Institute (INVIMA) (Colombia)
  • Ministry of Health (Costa Rica)
  • Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) (Peru)
  • Asociación Nacional de Medicamentos, Alimentos y Tecnología (ANMAT) (Argentina)
  • Oficina de Inscripción Control de Equipos Médicos y Para Médicos (OICEM) (Venezuela)
  • National Institute of Hygiene and Tropical Medicine (ECUADOR)
  • Ministerio de Salud (URUGUAY)
  • Directorate of Medicines and Health Products (DIRMED) (El-Salvador)
  • Health Registration Law by the Dirección General de Servicios de Salud (GUATEMALA)
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Animal Surgery
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American Preclinical Services has an extensive surgical program to meet all of your model development, treatment, and/or implant requirements. Our surgeons are Doctors of Veterinary Medicine or Academy of Surgical Research certified and have trained with some of the most prominent doctors and researchers in the field.

Although... Show more »

American Preclinical Services has an extensive surgical program to meet all of your model development, treatment, and/or implant requirements. Our surgeons are Doctors of Veterinary Medicine or Academy of Surgical Research certified and have trained with some of the most prominent doctors and researchers in the field.

Although APS' surgical staff is experienced and equiped with all the necessary tools to support your entire procedure, we also provide ala carte services to support your preclinical needs. Interested in having your key opinion leader (KOL) or design team personnel work with your product, no problem. The APS team will fill in the necessary gaps in procedure roles to allow your staff to concentrate on their duties during the implant or treatment procedure.

All of APS' surgical suites are maintained to hospital standards. Every suite features complete temperature and humidity control, with HEPA filtration providing for a full aseptic surgical field.

APS is experienced in following surgical models and device product testing:

Cardiovascular

  • Cardiopulmonary Bypass
  • Transapical Cardiac Valves (aortic, mitral)
  • Surgical Cardiac Valves (aortic, pulmonary, mitral, annuloplasty)
  • Annuloplasy Rings
  • Mitral Valve Regurgitation Therapy
  • Indwelling PICC Catheters
  • Arterial Vascular Grafts
  • Arteriovenous Fistulas
  • Left Ventricular Assist Device (LVAD)
  • Total Artificial Heart (TAH)

Dermal

  • Skin flaps
  • Wound Healing Models (partial and full thickness)

Gastrointestinal

  • Obesity Devices
  • GERD
  • Endoscopy / Laparoscopy
  • Biliary Catheter

Orthopedics

  • Orthopedic Connectors
  • Orthopedic Prostheses
  • Craniotomy / sinus studies
  • Dural implants
  • Endochrondral defects
  • Meniscectomy
  • Osteoarthritis

Pulmonary

  • Airway denervation
  • Lung Volume Reduction
  • Lung Biopsy
  • Tracheal Stent
  • Apnea Therapy

Urogenital

  • Kidney Cellular Regeneration
  • Prostate Ablation
  • Urinary Incontinence Meshes
  • Uterine Ablation
  • Hernia Repair
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Project and Process Management
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Regulatory Affairs Services
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Animal Models and Studies
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Animal Model in vivo Analyses
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Animal Physiology Analyses
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Animal Models of Disease
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Pain/Neuropathy Animal Models
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Bone/Cartilage Animal Models
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Clinical Research
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Clinical Laboratory Services
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Clinical and Anatomic Pathology
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Spectroscopy
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Mass Spectrometry
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Liquid Chromatography Coupled Mass Spectrometry Methods
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Other Mass Spectrometry Methods
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Medical Devices & Diagnostics
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Respiratory Disease Animal Models
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Respiratory Disease Animal Models Services

Respiratory Disease Animal Models Services

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