Regulatory Affairs and Electronic Publishing

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  • Domestic and international consultation and development of regulatory strategies (i.e. identifying critical path issues and approval pathways).

  • Preparation and submission of regulatory review designations, i.e. orphan drug, fast-track, breakthrough, etc.

  • Regulatory meeting support (pre-IND, EOP2, pre-NDA, and ad-hoc) including preparation of meeting questions for optimal Agency outcomes; preparation and submission of meeting requests and briefing packages; attending and facilitating meetings and rehearsals.

  • Regulatory review and approval of SAEs; change control for reporting requirements.

  • Regulatory review and approval of critical clinical documents for initial release of clinical trials material to clinical sites.

  • Regulatory Issue Remediation (Regulatory Inspection Findings, 483s, Warning Letters, Consent Decrees). 

  • Authoring, assembling, validating and/or submission-readying or review of regulatory submissions and registrations (including but not limited to INDs, CTXs, NDAs, BLAs, DMFs, and BMFs, briefing documents, meeting requests, scientific advice, orphan product designations, requests for Fast-Track designation, etc.)

  • IND (or equivalent) maintenance activities, including but not limited to preparation of IND Annual Reports or DSURs and PSURs; creating safety reports; handling information and protocol amendments.

  • Electronic submission publishing services and submission of regulatory documents through the FDA or other regulatory gateways.