Managed Projects
Regulatory Submissions
We'll work with you in 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 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
Our experts prepare all major regulatory submissions and provide extensive quality control reviews for all trial-related documentation, such as:
- Regulatory Agency and IRB/EC submissions
- Procurement of Import/Export license
- Initial submissions, amendments, notifications, and closeout submissions
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
Our team of experienced regulatory scientists can write the nonclinical, clinical, and CMC sections in CTD and traditional format for your new drug and biologic applications.
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