Regulatory Compliance Services

PharmaSolve Technical Advisores LLP, We provide comprehensive regulatory compliance services to help clients navigate complex regulations and ensure adherence to industry standards. Our expert team offers guidance on submissions, audits, and ongoing compliance strategies tailored to specific business needs.

  • Drug master file (Open part & Closed part)
  • CEP/COS (EDQM submission)
  • European Drug master file (ASMF)
  • US DMF
  • eCTD compilation
  • DMF-Life cycle management
  • Technical packages
  • US Agent appointment
  • DMF review (as per ICH guidance)