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.
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