Regulatory Services

We provide exemplary Regulatory compliance services that cover the complete life-cycle of the following healthcare products:

Prescription & OTC Drug Products;

  • Clinical Trial Application (CTA – Canada & IND - US)
  • OTC drugs (DINA), NDS & ANDS Submission in Canada
  • NDA & ANDA Submission with US FDA
  • Canadian DEL application & amendment
  • FDA Drug Listing & Establishment Registration
  • Post-Approval Changes Submissions & Notifications
  • Annual Product Quality Review Preparation
  • Product Monograph & Label review for Canada & US
  • API DMF Compilation, Submission and Representation
  • NAFDAC Regulatory submissions for Rx and OTC Drug products in Nigeria

 Medical Devices;

  • Investigational Study Application (ITA – Canada & IDE - US)
  • Class II, III & IV Medical Device Licence Application in Canada
  • EU Technical File Preparation
  • FDA PMA & 510(k) Notification
  • FDA Device Listing & Establishment Registration
  • Post-Approval Amendments Submissions & Notifications
  • New Canadian MDEL Application, amendment and renewal
  • NAFDAC Regulatory submissions for Medical devices in Nigeria

 Natural Health Products (only in Canada);

  • Product Licence Application (PLA) for new product
  • Product Licence Amendment
  • Site Licence (SL) Application, Renewal & amendment
  • Addition of Foreign or Local sites to existing Site Licence
  • Ingredient review for claim support evidences & addition to NHPID
  • Product Label review for Canadian Compliance
  • NAFDAC Regulatory submissions for Herbal medicinal products in Nigeria

Cosmetic Products;

  • Cosmetic Label and Ingredients review against Canadian, EU & US (FDA & State) Regulations
  • Canadian & EU Mandatory Cosmetic Notification
  • US Voluntary Cosmetic Notification
  • EU Cosmetic Product Information File & Cosmetic Product Safety Report Preparation
  • NAFDAC Regulatory submissions for Cosmetics in Nigeria

Low Risk Veterinary Health Products (LRVHP - Canada);

  • Ingredient review for LRVHP admissibility
  • Product Label & Claims review for LRVHP compliance
  • Obtain Notification Number (NN) via Interim Notification Program
  • Annual NN renewal & Amendment

Feel free to contact us with your request for review and quote.
Your One-Stop Solution to Healthcare Products Regulatory Compliance!
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