Leading-edge scientific services in product discovery and development

(Pharmaceuticals, Biologics and Immunotherapeutics, and Devices)

 

CCS Associates Transitions to eCTD for Submissions to Regulatory Agencies

 

CCSA in Action

CCSA Volunteers: Resource Area for Teaching

 

CCSA's Dr. Cathy Holmes Represents Cancer Survivors at Moonshot Summit

 

Announcement

CCSA Continuing Partnership with Alliance for Clinical Trials in Oncology Foundation

 

Precision Medicine - A Rising Star in the New Moonshot for Cancer

Dr. Caroline Sigman and Dr. Gary Kelloff provide a precision medicine update.

 

Lower Cholesterol May Lower Breast Cancer Risk

Featured Article by CCSA Scientist Amie Franklin

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

Strategic Planning

CCS Associates 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.

Bioinformatics

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

Pharmacovigilance

Safety is vital when conducting clinical trials.

Scientific and Medical Writing

Our scientists and medical writers bring extensive scientific research skills to preparing materials to support our clients’ programs.

Library Services

CCSA’s library provides a comprehensive approach to scientific literature searches using a variety of bibliographic databases as well as information on the Internet that may not be contained in structured databases.

eCTD

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

PhD, RAC