Leading-edge scientific services in product discovery and development

(Pharmaceuticals, Biologics and Immunotherapeutics, and Devices)


CCS Associates Wins NIDA Regulatory Affairs Support Contract


CCSA Article of the Month

March: Caroline Sigman and Susan Keating


CCS Associates Transitions to eCTD for Submissions to Regulatory Agencies


Healthy Eating

Blueberry, Banana, and Chia Seed Smoothie


CCSA Interview

The Latest in Immunoprevention with Dr. Lata Mukundan



CCSA Continues Partnership with NHLBI's VITA


CCSA in Action

CCSA Walks for Alzheimer’s Research

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

Strategic Planning

CCSA has a strong record of providing consulting services on strategies for drug development.

Regulatory Affairs

Our team of toxicologists, chemists, pharmacologists, and regulatory affairs professionals work closely to move projects from conception to approval.

Early Development

Board-certified toxicologists, pharmacologists, chemists, biochemists, microbiologists, nutritionists, and other scientists with extensive experience in nonclinical research and development make it possible to meet project timelines and goals.

Clinical Trials

CCSA has wide-ranging experience managing and maintaining all regulatory documentation on behalf of sponsors during the complete study lifecycle.


CCSA’s Bioinformatics and Data Management departments work together to provide high-quality, cost-efficient solutions for all of our projects.


CCSA provides meticulous pharmacovigilance to maintain the safety essential for successful clinical trials.

Scientific and Medical Writing

Our scientists and medical writers bring extensive scientific research, writing, and editing skills to preparing materials in support of client programs.

Library Services

CCSA’s library provides a comprehensive approach to scientific literature searches using a variety of bibliographic databases as well as information from the Internet.


eCTD is the electronic transfer of information to regulatory agencies based on the Common Technical Document (CTD) format. eCTD utilizes PDF documents linked via an XML backbone.

Our quality and risk management philosophy emphasizes open and frequent communication with all project team members so that requirements are clearly understood, changes are noted, challenges are addressed, and plans are executed to produce the best possible outcome.

Thank you for submitting such a high quality IND and responding to FDA's questions and requests promptly and diligently.

Biopharmaceutical Product Development Company

Thank you all for your excellent and speedy comments/suggestions. No bounds to my appreciation. You have done an amazing job!