GxP and Regulatory Consultancy


We provide rapid, comprehensive & effective advice to clients on a broad range of regulatory & technical issues, including:

Implementation of a compliant quality management system

    Advice on legal and regulatory issues including:

  • Patent challenges
  • Citizen’s petitions
  • Litigation
  • Assistance with responses to regulatory inspections
  • FDA 483s, deficiency letters, warning letters
  • Review of validation plans
  • Quality and regulatory audits