Services - Regulatory Affairs Many of our clients are smaller biotechnology companies who come to us for comprehensive regulatory guidance.  As a result, we are experienced in virtually every nuance of the regulatory process, from developing pre-clinical strategies through final submissions.  Before laying the blueprint for a product's regulatory program, we thoroughly assess existing product literature and the competitive and regulatory environment to define the most expeditious approach to obtaining registration.     Regulatory Affair Services include: Regulatory development strategies Regulatory submissions: IND, IDE, NDA, PMA, PLA, 510(k) Regulatory Liaison GLP, GCP, GMP training and auditing Quality assurance/quality compliance Literature search and review Medical Writing FDA meetings and presentations CANDAS     Home  |  About Us  |  Services  |  Experience  |  Training  |  Employment  |  Contact Us  |  Resources Copyright © 2004 Synergos All rights reserved. · Terms · Privacy Synergos · 2202 Timberloch Place, Suite 230 · The Woodlands, TX 77380 Phone: 281-367-6655 · Fax: 281-367-9679