Regulatory Service

Entry to the vast realm of pharmaceutical products in international markets requires a detailed understanding of complicated regulatory requirements. At Wellona Pharma, our Drug Regulatory Affairs (DRA) consultants assist companies to plan and manage their pharmaceutical and medical product development programs and regulatory requirements. We ease the process of getting swift approval for your products by defining country specific regulatory strategies right at the nascent stage of product development and eliminating potential roadblocks en-route to a successful product launch.

Our Regulatory Services include:
Registration Service:
  • DMF (CTD format) Preparation, Review and Submission
  • Dossier Writing and Review
  • Dossier Registration
  • COA, COPP
  • Notarization
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