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 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
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
- Biosimilars
- Gene therapy
- Blood products
- Small molecule
- New chemical entities (NCE)
- Antibodies
- 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
- Food additives
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
Explore our full range of commercialization services