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
and Europe 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
- Determination of regulatory status
- Review and support of manufacturing/GMP issues
- Pre-submission review of technical documents
- Critical writing and review of documentation
- Writing, review, and compilation of submissions:
- Clinical trial applications and notifications (IND, IDE, CTX, etc.)
- Marketing Application Support (NDA (CTD), BLA, ANDA, etc.)
- Orphan Drug, Treatment Use, and ANDA Suitability petitions
- Client representation before regulatory officials
MORIAH Consultants
4481 Paloma Lane
Yorba Linda, California 92886-2832
(714) 970-0790
(714) 970-0934 FAX