Regulatory Affairs (RA)

The regulatory elements of product’s development are a key component of getting a new product efficiently and successfully onto the market.  Given the time, effort and expense required to complete your submission, a dynamic regulatory strategy will ensure that you minimise risk and maximise speed in making submissions to gain the approval required.  GRA is able to advise on the most suitable regulatory strategy that spans product development with knowledge of both European and the US approval procedures.  We can help you to plan your submission routes and define which countries you should access first through to being hands on and actually writing the dossier with your appropriate input.

GreyRigge’s associates have many years experience of compiling dossiers, whether Clinical Trial Applications (CTA), Scientific Advice or Marketing Authorisation Applications.  We would partner with you to help compile your dossier to meet the planned milestone to get your product into the clinic as soon as possible.  Furthermore, we can also advise on post-licencing activities to ensure that products remain complaint with the latest regulations and what changes might be made to the product or process.

Ultimately we provide targeted solutions for the development and approval of your biopharmaceutical products.  We understand all facets of biopharmaceutical development as well as understanding the agencies in Europe and the U.S.  Most importantly we recognise the interests of our clients and that this is a business thus bring pragmatic, valid and compliant approaches to your products.