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.
- 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
- 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.