Our consultants work with clients with both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and carefully develop due diligence strategies. Our regulatory experts manage part of or the entire registration process for new drugs, biologics, generic products, and medical devices.
- Review of client technical dossiers and developmental plans
- Research and interpretation of regulations
- Determination of regulatory status
- Pre-submission review of technical documents
- Critical writing and review of documentation
- Clinical trial applications and notifications (IND, IDE, CTX, etc.)
- Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
- Orphan Drug, Treatment Use, and ANDA Suitability petitions
- Competent authority submissions
- Document authoring and coordination
- GMO applications
- CTA project management
- Ethics submissions
- Dossier preparation
- Life-cycle management of National, Mutual Recognition, Decentralised, and Centralised Procedures from preparation of initial MA applications through to full post-approval support and variations
- Full-service Regulatory Affairs Department
- Regulatory Strategy
Overflow Regulatory Affairs Department
- Training
Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:
- Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
- Coordinating clinical trial application filings to regulatory agencies
- Ensuring submissions comply with regulations
- Managing submissions and document storage processes
- Staying abreast of all regulations to ensure documentation compliance
