Filing Strategy

G&L recognizes the huge commercial value of accelerated drug development and market approval.

The company is a recognized expert in creating innovative regulatory roadmaps from early development right through to successful approval and beyond in any market around the world. G&L is relentless in the pursuit of excellence and quality in every aspect of its work and, as a result, has earned an exceptional reputation in the industry for getting things ‘right first time.’ Regulatory Development and Filing Strategy services include:

  • Agency meetings, Scientific Advice / Protocol Assistance
  • Advisory Committee meetings & preparation
  • Clinical Trial Filing (CTA and IND)
  • Investigator Brochure / IMPD / IND authoring
  • Risk management planning
  • Early Access Programs, PRIME, Breakthrough Therapy Designation
  • Paediatric Investigation Plans (PIPs), Orphan Designations
  • Expert Advice (Non-Clinical, Clinical and Quality)
  • Global Regulatory Intelligence

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