Regulatory Support

Our in-depth knowledge of global regulatory environments means we can guide you through the complexities of regulatory submissions and approvals.

Micron provides comprehensive support for the preparation and submission of regulatory applications such as INDs, NDAs, and BLAs.

We provide clinical and regulatory writing services throughout the product lifecycle, from preclinical through phases I–IV. Our experience of providing clinical/regulatory documents includes Investigator Brochures, Protocols, Clinical Study Reports, Responses to Regulatory Authority Queries, Patient Narratives, and Safety Reports (including periodic benefit-risk evaluation reports, PBRERs).