Bioregulatory Consulting is uniquely positioned to provide advice on regulatory strategy for early stage development to ensure that all aspects are considered and the best approach to risk mitigation taken.

We recognize issues, which can be problematic for the later stages of either out-licensing or registration, and provide quality advice to expedite drug development.

Bioregulatory Consulting (BRC) provides consultancy services to the biotech and pharmaceutical industry to assist with:

  • the development and registration of new therapies and
  • to expedite access to more affordable medicines by supporting the development of generics and biosimilars. BRC can either work in-house, on a short-term or long-term basis, or work externally on a project basis.

Services that BRC can provide include:

  • Preparation of regulatory strategy and advice to expedite development
  • Provision of guidance on chemistry, manufacturing and controls (CMC) issues in development and post-registration
  • Building the most effective scientific data package to facilitate out-licensing
  • Conducting gap analysis of the scientific data package for compliance with regulatory requirements for prescription medicines
  • Critical evaluation of scientific data prior to clinical development
  • Preparation of regulatory submissions for regulatory agency meetings, clinical trials or marketing applications
  • Advising on bridging studies: comparability exercise for CMC changes in development and post-registration
  • Rewriting dossiers to improve the readability and presentation of the data to facilitate the evaluation
  • Assisting in the development of biosimilars by designing comparability exercises for establishing similarity
  • Providing guidance on the analytical program to establish comparability between different scales and manufacturing processes
  • Arranging and participating in regulatory agency meetings