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Kinesys’ Experts will analyse your technology and your development and commercial objectives to produce a Regulatory and Development Roadmap. The Roadmap will address all relevant regulatory and development aspects related to your final objective (e.g. securing a licensing partner), including:

  • Potential non-clinical and clinical studies to support development and, specifically, the most expeditious pathway to the market or the most attractive pathway for a licensing partner, including the pros, cons and risks of the alternatives.
  • The regulatory path forward. This refers to the opportunity to secure designations and approvals that confer “regulatory recognition or validation”, such as PRIME, PIM, ATU and the US equivalents such as Breakthrough Therapy and Fast Track status.
  • What are the approximate timings to take the product to key value inflexion points in its development?
  • An analysis of the timings of the regulatory applications and potential clinical studies.
  • Consider the main CMC and nonclinical requirements for a successful Clinical Trial Application.
  • Consider the potential specific clinical study(ies) required in terms of design, scope and cost

The Regulatory and Development Roadmap is a live document that changes as data become available in development studies.

We bring our knowledge of real products and interactions with regulatory agencies to advise the best route forward for your products.

A Regulatory and Development Roadmap is particularly useful for early stage products and companies that have limited in-house regulatory resources but is also useful at later stages of a product’s development