Welcome to the new home of G&L Scientific. Same great company, great new look.

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Our Strategic Consulting Services

Our Strategic Consultancy is underpinned by unrivaled subject matter knowledge in every key area of Regulatory Affairs, Quality Assurance and Clinical Development.

Our Strategic Consulting Services

Our Services

Our Strategic Consulting services can be found below:

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  • Regulatory Strategy and Roadmaps
  • Pipeline and Portfolio assessments and Asset Optimization
  • Global market analysis and competitor intelligence
  • Clinical Development plans
  • Health Authority interactions (FDA Meetings, EU and global Scientific Advice)
  • Pre-IND, EOP2, Type A, B, C, INTERACT
  • Expedited Pathways; Fast Track, Breakthrough, Priority Review, RTOR, PRIME
  • Global Major regulatory filings; IND, CTA, NDA, BLA, MAA
  • Orphan Designation (ODD), Paediatric Plans (iPSP, PIP)
  • Chemistry, Manufacturing and Controls (CMC)
  • Medical and scientific writing
  • Risk management plans
  • Small molecules, biologics, cell and gene therapy
  • Due diligence (M&A)

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Discover how G&L can help you do business better

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