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Biotechnology, Biological and Biosimilar Products

We can help companies or individuals turn their concepts into reality by advising on their regulatory strategy so as to take the most effective and efficient route to market.  Through our strategic partnerships we can also offer advice on Intellectual Property (IP).

We believe it is vital to enlist the help of regulatory professionals during the early stages of a product's development so that a long-term strategy can be planned which will avoid costly mistakes being made.  This is particularly important when in discussion with the Health Authority(ies) and deciding on the best route to market.

It is essential that you define your product correctly as this will have lasting implications on your strategy.  For example, a biological medicinal product is defined by what it is, and usually by its source but … there are always exceptions.  GRS can support you in many ways, including:

  • defining your product
  • clinical trial design
  • regulatory strategy
  • preparation for Scientific Advice meetings
  • all quality activities (GxP)
  • marketing authorisation submissions and post-licence activities

Please contact us with your specific regulatory compliance requirements.