Expertise
Therapeutics
CSSi LifeSciences’ experience and knowledge provides clients with risk-based solutions and guidance that achieve success at each milestone in commercializing a novel drug.
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
A Successful Track Record
CSSi LifeSciences 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
Our team’s extensive experience with novel and complex drugs and medical devices includes:
Precision Medicine
Orphan and Rare Diseases
Personalized Medicine
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 regulatory services for therapeutics