AAPS Pharma

Search
Close this search box.

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