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InSymbiosis

Montreal, Quebec, CA

InSymbiosis is a contract research organization (CRO) that leverages a unique virtual CRO model or vCRO. Our model, which we also call our “drug development engine” enables us to provide highly customized drug development services to the global biopharma industry. Founded in 2005, InSymbiosis has a proven track record of supporting both small biotech and big pharma companies. InSymbiosis provide a “one-stop-shop” model where we offer enabling and integrated services for discovery, bioanalysis/analysis, drug safety assessment, chemistry, manufacture and control and clinical development. Our speciality is transitioning drug development candidates from preclinical to human clinical proof of concept across most therapeutic areas. What makes us further unique is our ability to provide our clients with dramatic cost saving solutions through our leveraging of a variety of novel cost reduction strategies. At the same time, our... Show more »

InSymbiosis is a contract research organization (CRO) that leverages a unique virtual CRO model or vCRO. Our model, which we also call our “drug development engine” enables us to provide highly customized drug development services to the global biopharma industry. Founded in 2005, InSymbiosis has a proven track record of supporting both small biotech and big pharma companies. InSymbiosis provide a “one-stop-shop” model where we offer enabling and integrated services for discovery, bioanalysis/analysis, drug safety assessment, chemistry, manufacture and control and clinical development. Our speciality is transitioning drug development candidates from preclinical to human clinical proof of concept across most therapeutic areas. What makes us further unique is our ability to provide our clients with dramatic cost saving solutions through our leveraging of a variety of novel cost reduction strategies. At the same time, our attention to scientific integrity, quality and regulatory compliance ensures that the programs outsourced to InSymbiosis withstand the rigours of regulatory authority scrutiny and investor due diligence. The result, InSymbiosis delivers a truly unique, game changing outsourcing solution to the biopharma industry.

Given the current climate, InSymbiosis believes that a new drug development paradigm is required in order to address patient needs, rising drug development costs and an uncertain financial environment.

Our vision is to be that new drug development paradigm.

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Radiolabeling
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Process and Scale-Up Chemistry
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Archive Management
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InSymbiosis maintains an electronic document and records management system as part of its Quality Management System (QMS). This electronic records management system incorporates a document structure for non-clinical and CMC documentation that follows the CTD structure allowing for easy transfer of information into regulatory... Show more »

InSymbiosis maintains an electronic document and records management system as part of its Quality Management System (QMS). This electronic records management system incorporates a document structure for non-clinical and CMC documentation that follows the CTD structure allowing for easy transfer of information into regulatory filings. In addition, our electronic records management system functions as an electronic Trial Master File (eTMF) to maintain clinical trial documentation. Our electronic records management system is used to maintain documentation for programs that we manage, but can also be used as a stand-alone system to house documentation as a service for our clients.

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Toxicology
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InSymbiosis has a vast amount of experience performing non-clinical GLP compliant toxicology and safety pharmacology programs to enable IND/IMPD as well as NDA submissions. Via our seasoned and experienced toxicology team, our client’s studies are placed at well-respected, GLP-compliant non-clinical CROs that have undergone... Show more »

InSymbiosis has a vast amount of experience performing non-clinical GLP compliant toxicology and safety pharmacology programs to enable IND/IMPD as well as NDA submissions. Via our seasoned and experienced toxicology team, our client’s studies are placed at well-respected, GLP-compliant non-clinical CROs that have undergone rigorous audits by the InSymbiosis Quality Group. From the planning stage of a program through to the regulatory submissions, InSymbiosis offers a comprehensive service that includes study strategy and planning, protocol development/review and finalization, study monitoring during all critical study stages and report review and finalization.

InSymbiosis and our vendors have significant experience performing toxicology studies for all compound classes across all species (including non-human primates) and administration routes (oral, intravenous/infusion, intraperitoneal, intramuscular, dermal, inhalation, intrathecal, epidural, intracerebral and intravitreal). Further, with validated study durations covering acute, subchronic, chronic and carcinogenicity, InSymbiosis can support drug safety assessment through to NDA submissions.

In addition, to complete the IND/IMPD package, InSymbiosis provide genetic toxicology services, as well as a comprehensive battery of safety pharmacology assessments for CNS, respiratory and cardiovascular safety assessments.

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Tablet Press Control Systems
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Tablet Compression Tooling
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Chemical Stability Testing
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Dermal Toxicology
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Product Stability Testing
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Scale-up Production
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Radiotracers and Radiopharmaceuticals
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Recombinant Protein Expression
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Chemical Process Consulting
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Drug Preformulation
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Preclinical Efficacy Studies
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Preclinical Study Design
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Pilot-Scale Filling
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Photostability Studies
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In vivo Pharmacology Studies
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Particle Analysis and Characterization
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Solid Dosage Packaging
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Packaging Consulting
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Powder Packaging
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Injectable Packaging
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Seal Integrity Testing
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Packaging Development
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Cream and Ointment Packaging
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Clinical Trial Packaging
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Packaging Certification
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Blister Packaging
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Compound Synthesis
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Blending
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Microscopic Analysis
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Micronization
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In vitro Metabolic Stability Assays
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Medicinal Chemistry
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Mass Spectrometry
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Topical Manufacturing
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Tablet Manufacturing
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Pre-Filled Syringe Manufacturing
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Controlled Release Systems
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Solution and Suspension Manufacturing
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Semisolid Manufacturing
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Protein Manufacturing
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Powder Manufacturing
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Peptide Manufacturing
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Aerosol Manufacturing
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Parenteral Manufacturing
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Drug Manufacturing
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Sterile Manufacturing
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Non-Sterile Manufacturing
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Custom Manufacturing
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Controlled Substance Manufacturing
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Manufacturing Consulting
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Clinical Trials Supply Manufacturing
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Compound Manufacturing
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Lyophilization
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Hit to Lead and Lead Optimization
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InSymbiosis’ lead optimization experience allows us to rapidly transition lead compounds to candidates ready for formal preclinical IND enabling studies. Our network of experienced vendors allows us to offer our clients a full range of lead optimization services including in vitro ADME profiling, pharmacokinetic studies and... Show more »

InSymbiosis’ lead optimization experience allows us to rapidly transition lead compounds to candidates ready for formal preclinical IND enabling studies. Our network of experienced vendors allows us to offer our clients a full range of lead optimization services including in vitro ADME profiling, pharmacokinetic studies and bioanalysis, hERG testing and other cardiovascular safety assessments. Further, through access to a range on animal models via both CRO and academic collaborations, InSymbiosis is able to provide animal proof of concept studies across a wide range of therapeutic indications.

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IND/NDA/BLA Submission
Investigational New Drug/New Drug Application Submission
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Animal Model in vivo Analyses
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In vivo Immunotoxicity Testing
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Immunobiology Services
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HPLC
High Performance Liquid Chromatography
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High Throughput Screening (HTS)
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Pharmaceutical Formulation
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Forced Degradation Studies
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Drug Potency and Efficacy Testing
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Drug Discovery
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Through combination of InSymbiosis’ drug discovery expertise and our network of discovery stage vendors, InSymbiosis can set up and execute drug discovery and hit-to-lead services and discovery collaborations. InSymbiosis have experience with multiple drug target families and the coordination of integrated biology and chemistry... Show more »

Through combination of InSymbiosis’ drug discovery expertise and our network of discovery stage vendors, InSymbiosis can set up and execute drug discovery and hit-to-lead services and discovery collaborations. InSymbiosis have experience with multiple drug target families and the coordination of integrated biology and chemistry efforts through either high-throughput screening approaches or more focused medicinal/discovery chemistry strategies. With experience in target cloning, cell line generation and assay development, InSymbiosis can support all of aspects of a drug discovery program.

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Drug Development
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Regulatory Affairs Consulting
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InSymbiosis provides regulatory support to our clients by leveraging internal expertise. Our scientific experts have significant experience in designing non-clinical toxicology programs to support regulatory filings worldwide. They can also provide guidance to streamline manufacturing and testing strategies in Phase I through III... Show more »

InSymbiosis provides regulatory support to our clients by leveraging internal expertise. Our scientific experts have significant experience in designing non-clinical toxicology programs to support regulatory filings worldwide. They can also provide guidance to streamline manufacturing and testing strategies in Phase I through III clinical programs while ensuring that the clinical trial material (CTM) meets regulatory requirements. InSymbiosis also has the capability of authoring both non-clinical safety as well as CMC sections of regulatory filings. InSymbiosis works in collaboration with a network of regulatory consultants who are able to prepare and submit regulatory filings on behalf of our clients.

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Audit and Inspection Consulting
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Chemistry, Manufacturing and Controls (CMC)
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Phase II Clinical Trials
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InSymbiosis offers a very unique service for clinical trials. The uniqueness stems from our vCRO business model that combines InSymbiosis expertise in clinical trial planning and management together with a range of world class clinical CRO partners within our network. The result is InSymbiosis’ ablity to support our client’s... Show more »

InSymbiosis offers a very unique service for clinical trials. The uniqueness stems from our vCRO business model that combines InSymbiosis expertise in clinical trial planning and management together with a range of world class clinical CRO partners within our network. The result is InSymbiosis’ ablity to support our client’s clinical needs from the planning stage, though regulatory strategy to trial execution.

We are able to conduct Phase I – IIa trials in practically all therapeutic areas in both healthy volunteers and special populations as well as Phase IIb and III trials in a large range of therapeutic areas. Further, the trials can be centered on Canadian investigator sites or global, multinational trials. The services we provide through our partnership with leading CROs covers the full range of clinical services including project management, study monitoring, biostatistics, data management, patient recruitment, central laboratory, global safety and pharmacovigilance. The bioanalysis expertise brought to the table by our team and our CRO network provides support to all of our client’s clinical bioanalytical needs. In addition, we are able to support the custom development of diagnostic assays and biomarker assays to complement our client’s complex clinical trial designs.

Given the importance of clinical studies in the drug development process, the selection of the right CRO partner is paramount. Further, clinical studies are typically the most costly part of a drug development program making the selection of a CRO also a key budgetary decision. What InSymbiosis provides is a truly different way to outsource your clinical studies through our vCRO model that allows selection from a range of qualified and experienced CRO partners together with leveraging our financial tools to drive budget reductions.

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Phase I Clinical Trials
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InSymbiosis offers a very unique service for clinical trials. The uniqueness stems from our vCRO business model that combines InSymbiosis expertise in clinical trial planning and management together with a range of world class clinical CRO partners within our network. The result is InSymbiosis’ ablity to support our client’s... Show more »

InSymbiosis offers a very unique service for clinical trials. The uniqueness stems from our vCRO business model that combines InSymbiosis expertise in clinical trial planning and management together with a range of world class clinical CRO partners within our network. The result is InSymbiosis’ ablity to support our client’s clinical needs from the planning stage, though regulatory strategy to trial execution.

We are able to conduct Phase I – IIa trials in practically all therapeutic areas in both healthy volunteers and special populations as well as Phase IIb and III trials in a large range of therapeutic areas. Further, the trials can be centered on Canadian investigator sites or global, multinational trials. The services we provide through our partnership with leading CROs covers the full range of clinical services including project management, study monitoring, biostatistics, data management, patient recruitment, central laboratory, global safety and pharmacovigilance. The bioanalysis expertise brought to the table by our team and our CRO network provides support to all of our client’s clinical bioanalytical needs. In addition, we are able to support the custom development of diagnostic assays and biomarker assays to complement our client’s complex clinical trial designs.

Given the importance of clinical studies in the drug development process, the selection of the right CRO partner is paramount. Further, clinical studies are typically the most costly part of a drug development program making the selection of a CRO also a key budgetary decision. What InSymbiosis provides is a truly different way to outsource your clinical studies through our vCRO model that allows selection from a range of qualified and experienced CRO partners together with leveraging our financial tools to drive budget reductions.

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Clinical Trial Management
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InSymbiosis offers a very unique service for clinical trials. The uniqueness stems from our vCRO business model that combines InSymbiosis expertise in clinical trial planning and management together with a range of world class clinical CRO partners within our network. The result is InSymbiosis’ ablity to support our client’s... Show more »

InSymbiosis offers a very unique service for clinical trials. The uniqueness stems from our vCRO business model that combines InSymbiosis expertise in clinical trial planning and management together with a range of world class clinical CRO partners within our network. The result is InSymbiosis’ ablity to support our client’s clinical needs from the planning stage, though regulatory strategy to trial execution.

We are able to conduct Phase I – IIa trials in practically all therapeutic areas in both healthy volunteers and special populations as well as Phase IIb and III trials in a large range of therapeutic areas. Further, the trials can be centered on Canadian investigator sites or global, multinational trials. The services we provide through our partnership with leading CROs covers the full range of clinical services including project management, study monitoring, biostatistics, data management, patient recruitment, central laboratory, global safety and pharmacovigilance. The bioanalysis expertise brought to the table by our team and our CRO network provides support to all of our client’s clinical bioanalytical needs. In addition, we are able to support the custom development of diagnostic assays and biomarker assays to complement our client’s complex clinical trial designs.

Given the importance of clinical studies in the drug development process, the selection of the right CRO partner is paramount. Further, clinical studies are typically the most costly part of a drug development program making the selection of a CRO also a key budgetary decision. What InSymbiosis provides is a truly different way to outsource your clinical studies through our vCRO model that allows selection from a range of qualified and experienced CRO partners together with leveraging our financial tools to drive budget reductions.

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Clinical Trial Monitoring
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Clinical Sample Analysis
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Chemical Analysis
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Stable Cell Line Generation
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Animal Blood Collection
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Biologic/Biosimilar Development
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Bioprocess Development and Scale-Up
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Biopharmaceutical Process Development
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Biopharmaceutical Manufacturing
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Bioanalytical Assays
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Bioanalysis, a crucial part of non-clinical studies, is also a key strength of InSymbiosis. From development of bioanalytical methods for all molecule classes (small molecules, peptides, proteins and antibodies, antisense etc), through to their GLP validation and sample analysis, InSymbiosis is well positioned to support all of... Show more »

Bioanalysis, a crucial part of non-clinical studies, is also a key strength of InSymbiosis. From development of bioanalytical methods for all molecule classes (small molecules, peptides, proteins and antibodies, antisense etc), through to their GLP validation and sample analysis, InSymbiosis is well positioned to support all of our clients bioanalytical needs. In addition, InSymbiosis have significant experience developing and validating anti-drug-antibody assays through to their effective incorporation into non-clinical programs for biologic compounds.

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Bioanalytical Analysis LC/MS/MS
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Aseptic Processing
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Solubility and Dissolution Testing
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Animal Model Housing and Maintenance
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Analytical Validation
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Analytical Method Development
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Assay Development
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Analytical Chemistry Services
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Accelerated Stability Testing
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Chemistry and Materials
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Experimental Design
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Biology
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Animal Models and Studies
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Veterinary Research & Diagnostic Services
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Mammalian Cell Culture
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Synthetic Chemistry
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Clinical Imaging Services
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In vitro Disease Models
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Imaging & Spectroscopy
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Bioanalysis
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Purification Services
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Protein Services
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Biochemistry & Molecular Biology
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In vivo PK/PD Studies
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Chromatography
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Microscopy
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In vitro ADME
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Protein Expression
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Strength Analysis
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Physical Analysis Methods
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Manufacturing Services
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Physical Processing
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Immunoassays
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Microbial Fermentation and Bioprocessing
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Lead Identification and Validation
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Radiochemistry
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Formulation Services
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Hit Identification
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Spectroscopy
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Regulatory Affairs Services
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Liquid Chromatography
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Cell and Tissue Culture
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Process Consulting
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Microbiology Services
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Packaging Services
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Engineering
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Cells and Tissues
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Clinical Sample Services
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Peptide Synthesis
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Pharmacology & Toxicology
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Clinical Trials, Consulting, and Management
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In vivo Toxicity Testing
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Drug Discovery & Development
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Clinical Research
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Bioavailability and Bioequivalence Studies
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Project Management, Consulting, & Support Services
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Product Development, Testing, and Packaging
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Veterinary Laboratory Services
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