An expert Medical and Regulatory Team on-board from Day 1

We provide an experienced Medical Team to support you in setting up:

  • the Medical Affairs function
  • the regulatory and licencing approval process
  • an approval and compliance process
  • initial Advisory Boards and producing relevant press briefings prior to launch.
A clear vision of the regulatory and investment strategy gives you the ability to maximise your product’s global development.

Our expertise includes:

  • Initial product review and investment analysis
  • Venture capital provision and introduction
  • Crowdfunding representation
  • Company and Medical Affairs function set up
  • Commercial partner introductions
  • Regulatory strategy, driving fast “Go / No Go” decisions
  • Expert representation at Agency scientific advice meetings
  • SOP writing and implementation
  • Assisting company set up in the UK from other
    international markets
  • Protocol development and clinical study programme implementation
  • Copy approval and compliance

Case Study

A US based biotech company needed a medical function to be rapidly set up in the UK to support the UK and European team of two advanced biotechnology products.  PharmaMedic provided a Consultant Medical Director to support a Consultancy Marketing Director.

Working was “virtual” for the first one and a half years with SOP development, compliance and regulatory advice. A second medical team member provided documentation to support an MHRA “Early Access to Medicines” (EAMS) process. This was successful. The company launched its first product at the end of Year 2. A full time Medical Director was appointed. PharmaMedic continues to provide compliance and final signatory services.

What our clients say about us

 “Malcolm provided support to Santen UK from its early start-up phase through to the current successful dedicated speciality company we are today. His medical affairs expertise and knowledge of UK regulations were invaluable during this critical start-up phase. We wouldn’t hesitate in working with Malcolm and his team at PharmaMedic again.”
Craig Wallace, MD at Santen

Get in Touch

If you are a Company or Team looking to work with PharmaMedic Consultancy or you wish to discuss our services, please contact us.

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