Therapeutics & Medical Devices

Expertise

Impactful, Knowledgeable Experience

CSSi LifeSciences’ experience and knowledge provides clients with risk-based solutions and guidance that achieve success at each milestone along the path to commercialization of a novel drug or medical device.

Our team’s extensive experience with complex therapeutic products and medical devices includes:

Biologics, cell products and gene-based therapies

New chemical entities

Generic drugs

In vitro diagnostics and rapid antigen testing

Nutritional food supplements

Drug-device combination products

Blood products

To ensure your project’s success, we are committed to providing:

A single point of contact for all project phases

A strategic, global approach to regulatory planning and product development

Expertise in a wide range of therapeutic indications

Optimized compliance throughout the product lifecycle

A global clinical site network

An integrated ecosystem of support services

A Successful Track Record

The CSSi LifeSciences Team has made a difference through expertise and resources to achieve unparalleled industry success.

Over 30 FDA Special Designations granted

Over 250 FDA CDRH Class 1 and 2 medical device submissions with 100% success

Experience with over 500 drugs and therapeutics

Over 65 FDA NDA, BLA, 505(b)(1) and 505(b)(2) successful submissions

Drug and Biologic Expertise

Our team is well-versed in the global regulatory environment and early clinical trial requirements for a full range of drugs and biologics.

Our experience includes:

  • Biologics
    • Cell-based therapies
    • Antibodies
    • Biosimilars
    • Gene therapy
    • Blood products
  • Small molecule
    • New chemical entities (NCE)
    • Peptides
    • Generics—505(b)(1) and 505(b)(2)
  • Vaccines, including BSL Level 2-3 select agent(s)
  • Generally Regarded as Safe (GRAS)
  • Over the Counter (OTC)
  • Veterinary medical products (CVM)
  • Medical foods
  • Supplements

Medical Device Expertise

Our team possesses a deep understanding of the global regulatory environment and clinical trial requirements for medical devices and diagnostic products. 

Our experience includes:

  • Diagnostic tests
  • Drug-device combination products
  • In vitro laboratory and companion diagnostics (IVD)
  • Rapid antigen test kits
  • Diagnostic imaging devices and systems
  • Medical device software, wireless systems, and mobile apps
  • Bio-engineered and tissue-engineered products
  • Surgical tools, systems, and accessories
  • Drug delivery platforms
  • Implants
  • Wearables
  • Artificial intelligence integrated systems

Explore our regulatory services for medical device technologies

Therapeutic Expertise

Our experience includes:

  • Allergy
  • Autoimmune
  • Cardiovascular
  • Dermatology
  • Female Health
  • Gastroenterology
  • Hematology
  • Immunology
  • Infectious Disease
  • Metabolic and Endocrine
  • Neurology
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Pulmonary
  • Urology
  • Veterinary Medicine

Explore our regulatory services for therapeutic technologies

Commercialization Expertise

Our experience includes:

  • Investor readiness
  • U.S. market entry strategy
  • U.S. soft-landing and ecosystem integration
  • Subsidiary establishment and business licensing
  • C-suite talent acquisition
  • Advisory board recruitment and management
  • Pricing and reimbursement strategy
  • Market research and analysis
  • Product validation & customer discovery
Commercialization Expertise

Explore our full range of commercialization services