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


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