University Support

Regenerative medicine is different from many other areas of pharmaceutical development. Translation of these novel therapeutics to the clinic is often undertaken by academic research groups rather than pharmaceutical companies, and many developers are university spin-outs: very small or virtual companies. Although these groups are aware of the importance of regulatory input into product development, it is often difficult for them to access regulatory expertise on a basis which suits the financial constraints and frequently grant-oriented nature of these projects.

We offer a full range of services and assistance to academic groups:

 

Classification of new product concepts

  • The increasing complexity of new therapeutic approaches may make classification of new concepts quite challenging, especially where cells or tissues are combined with elements of medical devices and/or conventional medicinal substances. Expertise in interpreting all of the relevant legislation is essential; our extensive background with both medicinal products and medical devices is invaluable in making correct classification decisions

Input into grant applications

  • We can provide any input from a quick review of existing content  to development of a full section on regulatory requirements and strategy
  • Letters of support (usually complimentary)
  • Recognising the unique challenges of timing for grant applications, we can usually provide very fast turnaround of review and comment for grant applications

Design and development plans

  • Roadmap documents providing guidance on regulatory requirements at each project stage, strategic considerations and data submission documents can be prepared at any level of detail
  • Any level of input can be provided, from a simple initial overview to full project support including regulatory submissions

Training

  • Bespoke training is available to cover all aspects of regulation and development of advanced therapy medicinal products, biomaterials, combination products and other regenerative medicine concepts
  • Individual training programmes can be provided, from general overviews to detailed coverage of specific areas