Therapeutics & Medical Devices
Expertise
Impactful, Knowledgeable Experience
CSSi LifeSciences’ experience and knowledge provides clients risk-based solutions and guidance that achieve success at each milestone for commercializing a novel drug or medical device.
Our team’s extensive experience with novel and complex drugs and medical devices includes:
Precision Medicine
Orphan and Rare Diseases
Personalized Medicine
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
1st
Extensive “first-in-class” and “first in” indication experience
Over 65 FDA NDA, BLA, 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
- Antibodies
- Peptides
- Biosimilars
- Gene therapy
- Cell-based therapies
- Small molecule
- New chemical entities (NCE)
- Generics—505(b)(1) and 505(b)(2)
- Vaccines, including BSL Level 2-3 select agent(s)
- Generally Regarded as Safe (GRAS)
- Blood Products
- 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)
- 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
Therapeutics Expertise
Our experience includes:
- Allergy
- Autoimmune disease
- 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:
- US market entry strategy
- US soft-landing and ecosystem integration
- Subsidiary establishment and business licensing
- C-suite recruitment
- Advisory board recruitment and management
- Pricing and reimbursement strategy
- Market research and analysis
- Product validation & customer discovery
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
Explore our full range of commercialization services