| |
Formal Regulatory Meetings |
- Pre-IND, EOP2, pre-NDA/BLA, pre-MAA and scientific Advice, CPMP, COMT, and Advisory Committee meetings (preparation and submission of requests and Briefing Documents, meeting preparation and rehearsals, and meeting participation
- Telecons and communications
- Post-meeting analysis, response and dispute resolution
- Maintenance of Archives for regulatory authority correspondence, meeting minutes, dossiers, and documents
|
|
