REGULATORY AFFAIRS

Our company is passionate about protecting our customers while ensuring that our businesses comply with all product-related regulations.

CMC strategy and planning from product development to new product filings, relevant health authority meeting support and interaction, due diligence, site rationalization, and submission coordination

  • CMC Modules 2.3 and 3, NDA/MAA and IND/CTA, dossier formulation

  • FDA deficiencies response

  • Stabilities studies reporting

  • Post approval changes

  • Reporting in CTD format