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Regulatory Strategy

We are experienced in giving strategic regulatory advice and have worked with small, medium and large companies, managing regulatory activities for clients in a virtual model.

Early Development:

  • Target product profile (TPP) and Quality TPP
  • Analyse development path and map out important regulatory challenges and milestones that need to be addressed.
  • Can advise on and guide you through regulatory pathways for novel and established products including accelerated pathways (e.g. PRIME (Priority Medicines)), conditional approval and adaptive pathways.
  • Experienced in taking products from discovery to Phase 1 IND/CTA, through the clinical stages to MAA/BLA and beyond.
  • Provide in depth CMC analysis of product & regulatory applications, including Quality by Design/CQAs.


Scientific Advice and Agency engagement (EU & FDA):

  • Help define and recommend agency interaction strategy.
  • Author briefing documents and identify questions.
  • Meeting preparation (face to face and telecon).
  • Participate in agency meetings for clients.
  • Meeting follow up including meeting minutes, assessment of Agencies feedback and follow-up strategies


Regulatory Submissions:

  • We will guide and assist you through all regulatory procedures including Clinical Trial and Marketing Authorisation application processes, scientific advice and all pre- and post- approval licence maintenance activities.