Regulatory affairs (RA) strategy is the most critical component of success with health authorities. It involves developing a roadmap to maximize available benefits, timing, and health authority (HA) expertise/feedback. It also involves knowing when to submit clinical and regulatory documents throughout the product development timeline and a regulatory review once documents are drafted.
You may only need a few hours of advice as you start to see the potential of your product in Drug Discovery, but that advice will prove invaluable as you move through the Nonclinical IND-enabling phase and get closer to your first IND/CTA regulatory submission. In the Clinical IND phase of your program, you will need a strong regulatory strategist who can guide you through HA interactions and direct you to programs that can expedite your product’s approval.
AO Regulatory Consulting develops and supports clinical, nonclinical, and CMC RA strategy for the following topics:
- Gap and risk assessment
- HA meetings with contingency preparation and guided interactions
- Expedited access pathways
- Orphan drug designation
- Pediatric planning
- Expanded access/compassionate use
- HA information request (IR) responses
- Clinical trial and investigational new drug (CTA/IND) applications
- Drug master files (DMF)