Regulatory Submissions & Development

Identifying your products classification is a combination of the ingredients used and the claims you make. Many people are surprised to hear that with small variations products like lip balms can be classified as a Cosmetic, NHP or a Drug. Knowing your products classification is the first step in launching it in Canada. However, many businesses have difficulty getting the answers they need and become frustrated by the processes in regulated markets. We uncover these answers on your behalf and guide you down the path to your products launch.

The Regulated Product Launch Pad provides the roadmap to getting your product to market with Health Canada, FDA and EMA concent. We take you through the following 3 stages;

Stage 1Review Stage. We review your (proposed) product claims and formulation and provide advice and guidance on areas where minor changes can have a major impact on how your product is classified.

Stage 2Product Submission. We complete all of the required paperwork and submit your product applications on your behalf. Once the product classification is received back from the regulator we review the submission to ensure it is an accurate classification.

Stage 3Product Launch Roadmap. Based on your products classification we create a detailed roadmap and checklist of all the required steps to distribute your product in your selected country. Finally, We review the roadmap with you to point out critical steps, common pitfalls and answer any questions you have on how to proceed.

For an even simpler solution, our importing and distribution service can ensure GMP & ISO compliance and manage the process of distributing your product across Canada and Internationally.

Product Regulatory Submissions Details

We handle product submissions to Health Canada, FDA and EMA for prescription and OTC pharmaceuticals, Natural Health Products and Medical Devices (Class II-IV) and Cosmetics. Negotiation of product submission specifics with regulatory authorities include:

  • Negotiating and submitting Clinical Trial Applications (CTA to Health Canada & INDs to the US)
  • Defining data requirements, preparing and building eCTD submissions
  • Authoring of CTD Modules 1, 2, 3, 4 and 5 reports and risk management plans as part of NDS/NDA submissions
  • Drafting and submitting PLAs for Natural Health Care Products and Supplements
  • Preparation of STED & Non-STED format Class III & Class IV device submissions
  • Reviewing of BA/BE study reports and data analysis for compliance to TPD requirements
  • Preparing post-market change assessments for regulated products in Canada

Facility Regulatory Submissions Details

We provide support for handling regulatory submissions, renewals, notifications and amendments through;

  • Direct application for Canadian Drug Establishment Licences, NHP Site Licences, and Medical Device Establishment Licences
  • Local certified distributors in Russia
  • Legal representative services & Registration Holders in Mexico