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CSSi LifeSciences

Glen Burnie, MD, US

Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. CSSi LifeSciences has successfully supported the development of hundreds of drugs, biologics, devices, and in-vitro diagnostics.

We are uniquely positioned to provide a comprehensive and scalable suite of services to develop therapeutic drugs and devices with cost-efficient predictability. We have the expertise to support lifecycle strategies that drive product value, extend market share, and maximize ROI.

Avoid the “large CRO shuffle” – We offer cost efficient, fully integrated expertise and services from start to finish.

CSSi LifeSciences has not listed any services.

Medical Device Clinical Trials
Price on request
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Regulatory Affairs Services
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Based on if the product is a drug, biologic or cell-based therapy and current stage of development, there are a variety of submissions that may be required by regulatory agencies in the US, Europe, Canada, and throughout the globe. Utilizing strategies designed to address regulatory concerns and minimize additional questions, our... Show more »

Based on if the product is a drug, biologic or cell-based therapy and current stage of development, there are a variety of submissions that may be required by regulatory agencies in the US, Europe, Canada, and throughout the globe. Utilizing strategies designed to address regulatory concerns and minimize additional questions, our team reviews, prepares and submits documents required for appropriate regulatory pathways.
Our team has prepared and submitted hundreds of successful regulatory documents, including:

  • Health Authority Interactions
  • Regulatory consulting
  • Clinical Operations
  • Regulatory and Scientific Communications
  • Proven FDA Advisory Committee Preparation Expertise
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Regenerative medicine
Oncology
Cushings Syndrome
Cardiovascular
Duchenne Muscular Dystrophy
Diabetes Type 1
Diabetes Type 2
ALS
Arthritis
Huntington's Disease
metabolic
Blood
Liver
Skin
Cardio
Dental
gastric
nervous system / brain
hematology
rare disease
metabolic
Acute Myeloid Leukemia (AML)
Acute Lymphocytic Leukemia (ALL)
Chronic Myelogenous Leukemia (CML)
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Fibrosis
Anemia
Benign Prostatic Hyperplasia (BPH)
Sjögren’s Syndrome
Antibiotic Development
Bacteremia
Diabetes
neurodegenerative disorders
Alzheimer
Inflammatory Bowel Disea
aging
cardiovascular
endocrine
dermatitis
dermatology
Electrophysiology
heart failure
atrial fibrillation
Autoimmune
CF
Breast Cancer
chronic obstructive pulmonary disease
Cardiomyopathy
Atherosclerosis
Central Nervous System
Maxillofacial
Gastroenterology
Infectious Disease
Obstructive Sleep Apnea
Regenerative Medicine
Wound Care
Central Nervous System
Peripheral Nervous System
Dental
Maxillofacial
Endocrinology
Women's Health
Gastroenterology
Infectious Disease
Obstructive Sleep Apnea
Ophthalmology
Orphan Disease
Orthopedics
Respiratory
Allergy
Urology
Preclinical Study Design
Price on request

Preclinical and nonclinical drug development is a critical component of drug development and making poor or misinformed decisions can significantly delay or kill a drug, and waste valuable resources and investments.

The goal of preclinical and nonclinical research must be strategically designed and aligned to support a drug... Show more »

Preclinical and nonclinical drug development is a critical component of drug development and making poor or misinformed decisions can significantly delay or kill a drug, and waste valuable resources and investments.

The goal of preclinical and nonclinical research must be strategically designed and aligned to support a drug approval. In addition, vital issues need to be considered early, such as the timing of “must have” and “nice to have” studies, as well as issues ranging from which animal species would be most appropriate, to which facility can validate the bioanalytical assay or scale up and supply GMP API.

CSSi LifeSciences™ provides strategic guidance, planning and execution to save you time and costs.

« Show less
Regenerative medicine
Oncology
Cushings Syndrome
Cardiovascular
Duchenne Muscular Dystrophy
Diabetes Type 1
Diabetes Type 2
ALS
Arthritis
metabolic
Blood
Dental
nervous system / brain
hematology
rare disease
metabolic
Acute Myeloid Leukemia (AML)
Acute Lymphocytic Leukemia (ALL)
Chronic Myelogenous Leukemia (CML)
Chronic Lymphocytic Leukemia (CLL)
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Fibrosis
Anemia
Sjögren’s Syndrome
Antibiotic Development
Diabetes
Alzheimer
Parkinson
Inflammatory Bowel Disea
cardiovascular
bladder
endocrine
dermatitis
dermatology
Autoimmune
CF
Any
Breast Cancer
Drug-Gene Regulation
Carcinogenicity
Genome
chronic obstructive pulmonary disease
Cardiomyopathy
Atherosclerosis
Central Nervous System
Dermatology
Endocrinology
Gastroenterology
Wound Care
Central Nervous System
Peripheral Nervous System
Dental
Maxillofacial
Endocrinology
Women's Health
Gastroenterology
Infectious Disease
Obstructive Sleep Apnea
Ophthalmology
Orphan Disease
Orthopedics
Respiratory
Allergy
Urology
Neurodegenerative
Clinical Trial Design and Consulting
Price on request

Transforming a new drug or biologic entity into a treatment opportunity is a complex, expensive, and time-sensitive process. We help you navigate through the clinical development process through all clinical phases.

PHASE 1 STUDIES

Simplifying the drug development pathway while planning for contingencies requires clinical... Show more »

Transforming a new drug or biologic entity into a treatment opportunity is a complex, expensive, and time-sensitive process. We help you navigate through the clinical development process through all clinical phases.

PHASE 1 STUDIES

Simplifying the drug development pathway while planning for contingencies requires clinical expertise and experience. CSSi LifeSciences™ is a proven partner that ensures that First-in-Human Phase 1 studies are designed to reduce time and expenses.

PHASE 2a/2b STUDIES

Based on the goals and early signs of safety and activity from the Phase 1 study, CSSi LifeSciences™ supports Phase IIa outcomes on an accelerated basis for approval through our integrated and adaptive study approaches. More importantly, our design methodology and operationalizing of studies increases success while considering the financial constraints. Following a successful proof-of-concept study, the product can progress to a Phase 2b or a Phase 3 study.

PHASE 3/3B STUDIES

CSSi LifeSciences™ has proven capabilities in advancing new drugs through late-phase clinical trials through well designed, Phase 3 studies, while obtaining rigorous data to satisfy multiple stakeholders, regulatory agencies, physicians and payers. Whether you need to position a product through comparative studies, develop line extensions or extend label claims, our process is designed to expedite study completion.

PHASE 4 AND EXPANDED ACCESS STUDIES

For a new drug to reach its intended market after launch, companies will need to:

  • Show safety/efficacy data from larger populations
  • Expand trust in target market
  • Prove regulatory compliance
  • Build recognition with key players through tactical marketing

Conducting an Expanded or Managed Access Program (EAP/MAP), whether under a Treatment IND, Emergency Use Protocol, Compassionate Use or Named Patient Basis program, requires specialized strategies, skills and resources that are different than a conventional clinical study.

We have the expertise, experience, and infrastructure to help navigate the complex regulatory and logistical issues of expanded access programs worldwide. Our approach utilizes cost effective, centralized management of Expanded Access Programs, combined with integrated drug supply and logistics to support any size program or market segment.

« Show less
Cancer
Regenerative medicine
Oncology
Cushings Syndrome
Cardiovascular
Duchenne Muscular Dystrophy
Diabetes Type 1
Diabetes Type 2
ALS
ALL
Arthritis
metabolic
Blood
Skin
Dental
gastric
nervous system / brain
hematology
rare disease
Acute Myeloid Leukemia (AML)
Acute Lymphocytic Leukemia (ALL)
Chronic Myelogenous Leukemia (CML)
Chronic Lymphocytic Leukemia (CLL)
Non-Hodgkin Lymphoma
Fibrosis
Anemia
Benign Prostatic Hyperplasia (BPH)
Sjögren’s Syndrome
Antibiotic Development
Bacteremia
anthrax
Diabetes
Alzheimer
Parkinson
Inflammatory Bowel Disea
aging
cardiovascular
bladder
endocrine
dermatitis
dermatology
heart failure
atrial fibrillation
Autoimmune
CF
Breast Cancer
chronic obstructive pulmonary disease
Cardiomyopathy
Atherosclerosis
Central Nervous System
Endocrinology
Gastroenterology
Infectious Disease
Wound Care
Central Nervous System
Peripheral Nervous System
Dental
Maxillofacial
Endocrinology
Women's Health
Gastroenterology
Infectious Disease
Obstructive Sleep Apnea
Ophthalmology
Orphan Disease
Orthopedics
Respiratory
Allergy
Urology
Neurodegenerative
Metabolic Disease
Clinical Data Management
Price on request
Request a quote for more information about this service.
Clinical Trial Monitoring
Price on request
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Medical Writing
Price on request
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Project Management & Consulting Services
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Scientific Communication
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Editorial Support
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Animal Models and Studies
Price on request
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Clinical Research
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Clinical Trials, Consulting, and Management
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Clinical Data Collection, Analysis and Management
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