Assemble and file an application.
Gaining regulators’ marketing approval is – together with launch – one of the two major value points in a drug’s life cycle. Marketing Authorization Applications (MAA), New Drug Applications (NDA) or Biologic License Applications (BLA) detail how the product is manufactured and controlled, and summarize years of testing.
Registration applications provide comprehensive information about the drug, enabling regulatory agencies to ensure that therapeutic benefits outweigh risks. Regulators assess quality, safety and efficacy, and evaluate the ability of the future marketing license holder to ensure and monitor a sustainable benefit/risk ratio. In addition to summarizing quality, nonclinical, and clinical data, marketing application submissions also present how the safety reporting system transitions from development to the post-approval phase.
Assemble and file MAA / NDA / BLA with required format
Detail roadmaps for submitting applications in various countries of interest, and managing review processes.
Set up RMP
Adapt post-approval safety surveillance to regional/national requirements.
Monitor safety profile, organize global safety review boards.
- Are clinical trial results adequate for both regulatory approval and market access?
- Where are the key challenges of the overall development, and how to present them?
- What are the national requirements & procedures?
- Can I obtain Accelerated Assessment Procedure, Fast track or Priority Review?
- Sequential or parallel submissions?
- What should be included in the Risk Management Plan?
- What is the optimal launch sequence?
- How to prepare for negotiations with payers?
- How about countries with a much lower price?
- Should patients’ and care partners’ opinions be integrated into the submission dossier?