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By Stage of Drug Development

Registration

Pre-Clinical Development Determine the safe dose for FIH study Early-Stage Clinical Development Assess efficacy, effectiveness and safety Late-Stage Clinical Development Gather data for registration and market access Registration Assemble and file an application Commercialization & Post-Launch Post-approval regulatory, lifecycle management

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.

Client Goals

File for registration

Assemble and file MAA / NDA / BLA with required format

Detail roadmaps for submitting applications in various countries of interest, and managing review processes.

Risk management

Set up RMP

Adapt post-approval safety surveillance to regional/national requirements.

Monitor safety profile, organize global safety review boards.

Stage of development: challenges

Challenges

  • 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?

Our mission

Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets.

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