AAPS Pharma

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Get our guaranteed expert guidance to navigate the long and challenging road to regulatory approval for your drug or medical device. Let us help make your Health Canada and US-FDA approval process smoother.

Our Services:

  • Regulatory strategy and planning, to maintain global regulatory compliance across the product
    life cycle
  • Regulatory gap analysis and compliance
  • FDA submission and related services
  • FDA – 483 responses
  • Pre-Approval Inspection (PAI) and readiness
  • Scientific and technical assistance
  • Regulatory writing
    > Common Technical Documents
    > Clinical and non-clinical overviews
    > Summary of product characteristics
    > Clinical expert statements
    > Briefing documents
    > IND/NDAs
    > Labelling and core data sheets