regulatory affairs

Well designed and implemented regulatory strategies are critical to getting a client’s product to market quickly and in a cost effective manner. Having worked with many US and international sponsors, ranging in size from small early stage development companies, to large international pharmaceutical, device and biotech institutions, Triligent has helped its clients develop sophisticated regulatory strategies meeting all US Code of Federal Regulation (CFR) and International Conference on Harmonisation (ICH) regulations and guidelines, while keeping to the clients’ time and budgetary goals.

Triligent distinguishes itself from other CROs by offering highly trained and experienced personnel that understand the intricacies of the research process regardless of the disease state being studied. We provide our clients with seasoned professionals, most with more than 15 years experience in their fields. Our professionals have gained their many years of experience from within the FDA, contract research organizations, and various US and international pharmaceutical, device and biotech companies. Our professionals regularly attend continuing education programs and participate as panel members in and chairs of internationally recognized seminars related to current US and international trends in regulatory related topics as well as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and/or Good Laboratory Practice (GLP).

Based upon the client’s requirements, we identify members of our team who will best serve the client’s project management needs and ask such personnel to volunteer for the project. Triligent has found that employing experienced and willing personnel on a project results in such personnel remaining on the job through to the end of the project, dedicated to providing the client with excellence and consistency in their services. The end result of Triligent’s efforts has been a highly stable operation producing outstanding results for our clients proved by Triligent’s high rate of repeat business.

regulatory affairs
  Triligent offers a full range of
international regulatory
services including:
  • Development and Implementation
    of Regulatory Strategy
  • Sponsor / FDA Liaison
    / Representation Document
    Preparation, Review
    & Submission
  • Regulatory Response
    Preparation
  • IND Consulting
  • NDA Consulting
  • Training