Regulatory Affairs

Our regulatory expertise ensures that regulatory strategies and alternatives are considered at every step to help you gain product registration as expeditiously as possible. In addition, our in-depth knowledge of regulatory requirements in North America, Europe and other regions allows you to avoid unnecessary delays and duplication and ensures top-quality documentation. MORIAH's global regulatory services include regulatory strategy development, submissions, consulting, and regulatory liaison.

Regulatory Services Include:

Review of client technical dossiers and developmental plans
Research and interpretation of applicable local regulations
Review and support of manufacturing/GMP and all GxP issues
Pre-submission review of technical documents
Critical writing and review of documentation
Writing, review, and compilation of submissions:
Clinical trial application support and notifications (IND, IDE, CTX, etc.)
Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
Orphan Drug, Treatment Use, and ANDA Suitability petitions
Company representation before regulatory officials