EXPERIENCE / EXPERTISE

Making a Difference Through Our Expertise

We provide solutions to accelerate drugs and medical device technologies from discovery to commercialization. CSSi LifeSciences has the experience to offer clients a headstart through a deep understanding of the expectations and guidance required to achieve success at each milestone for developing a novel drug or medical device.

Our team has extensive experience with novel and complex drugs and medical devices that includes:

TO ENSURE YOUR PROJECT’S SUCCESS, WE ARE COMMITTED TO PROVIDING:
  • Single point of contact for all project phases
  • Strategic, global approach to regulatory planning and product development
  • Expertise in a wide range of therapeutic indications
  • Optimized compliance throughout the product lifecycle
  • Global clinical site network
women working in a research lab

A Track Record of Success

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

  • Over 85 FDA NDA, BLA, 505(b)(2) successful submissions
  • Over 250 FDA CDRH medical device submissions with 100% success
  • Extensive “first-in-class” and “first in” indication experience
  • Over 30 FDA Special Designations granted
  • Through our extensive investor network, CSSi LifeSciences has assisted with raising over $700M USD
researcher working in a lab

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
    • Biosimilars
    • Gene therapy
    • Cell based therapies
  • Small molecule
    • New chemical entities (NCE)
    • Generics - 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
  • Nutritional supplements

Medical Device Expertise

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

OUR EXPERIENCE INCLUDES:
  • Drug-device combination products
  • In vitro laboratory and companion diagnostics
  • 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
  • Artificial intelligence integrated systems
researchers working in a lab
THERAPEUTIC EXPERTISE

Our Therapeutic Expertise For Drugs and Medical Devices Are Broad and Includes:

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