Regulatory Service

 

A regulatory agency's service, which may include but is not limited to examination.

Regulatory Service

Access to the enormous world of pharmaceutical items in international markets necessitates a thorough understanding of complex regulatory constraints. Welox Pharma's Drug Regulatory Affairs (DRA) consultants help companies plan and manage their pharmaceutical and medical product development projects, as well as their regulatory needs. We make it easier to secure quick approval for your products by creating country-specific regulatory strategies early in the product development process and removing potential hurdles on the way to a successful launch.

Our Regulatory Services include:

Our Regulatory Services include:
  • DMF (CTD format) Preparation, Review and Submission
  • Dossier Writing and Review
  • Dossier Registration
  • COA, COPP
  • Notarization
  • COA, COPP
Post-Approval Changes:
  • Product re-registration and
  • Renewal of site according to schedule
  • Post-approval lifecycle maintenance
  • Report compilation and publishing
Pre-Registration Service:
  • Drug Product DMF
  • Development & Preparation of documents
  • Content creation and document services