(650) 691-4400 info@ccsainc.com

About Us

We’re a dedicated team of experts passionate about transforming innovations into realities, committed to guiding you through every step of the pharmaceutical and device journey with integrity and excellence.

Who We Are

Over 4 Decades of Proven Success in Delivering Results

CCS Associates, Inc (CCSA) is a small business providing leading-edge scientific advisory services in pharmaceutical and device discovery and development to government agencies as well as the pharmaceutical and biotech industries.

CCSA was founded by Caroline C. Sigman, Ph.D., whose vision and leadership helped establish the company’s commitment to scientific excellence, integrity, and client partnership. Her dedication to advancing research and supporting complex clinical and regulatory programs continues to shape our culture and guide our work today.

The professional staff of CCSA includes MD, PharmD, PhD, MTech, MS, MPharm, MBA, MEd, MA, BS, and BA-level scientists with academic backgrounds and professional certifications in clinical research, pediatrics, organic chemistry, biochemistry, anatomy, physiology, genetics, carcinogenesis, pharmacology, immunology, toxicology, cell and molecular biology, biostatistics, computer science, microbiology, and virology.

Our Experience

Diverse Client Requests Tailored to Your Needs

We pride ourselves on our ability to respond to a diverse range of client requests, each tailored to meet the unique challenges of the pharmaceutical and biotech landscape. Whether it’s developing strategic frameworks, managing complex projects, leveraging data science for actionable insights, or providing essential site management services, our dedicated team is equipped to deliver results that exceed expectations. We also offer specialized scientific support to ensure that every aspect of the development process is addressed with precision and expertise, empowering our clients to navigate their paths from discovery to approval with confidence and clarity. These projects have led to a total of 5300+ IND, NDA, CTA, DMF, IDE, and INAD submissions.

IND

CTA

NDA

DMF

IDE

INAD