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Regulatory Interaction &
Submissions
- Assistance with pre-IND,
Type A, Type C, EoP2A, and EoP2 meetings, including preparation
of briefing package.
- Full IND preparation and maintenance capabilities as
well as targeted efforts on clinical pharmacology,
human PK/PD, and nonclinical ADME and toxicokinetic
sections.
- IMPD and international regulatory documents.
- NDA/BLA/CTD components (including CTD Module 2)
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