Global Regulatory Affairs Consulting is a provider of strategic solutions for your regulatory compliance and product registration needs.
We provide an efficient and customized approach to ensure timely delivery of market approvals from regulatory agencies for your products. Our consulting services cover the following product categories:
- Medical Devices
- Pharmaceutical Products
- Combination Products
- Natural Health Products
Our services include, but are not limited to, the following:
- Initial regulatory assessment of your product(s) to determine the proper and least burdensome regulatory approach for a smooth and timely market approval
- Product classification
- Submission preparation for regulatory product registration (e.g. Medical Device Licence Application, 510(k), Technical File, DINA, Product Licence Application (PLA), Cosmetic Notification)
- Management of post-approval product changes
- Preparation of investigational testing and clinical trial applications (e.g. IDE, ITA, CTA, IND)
- Label compliance assessment including label text preparation and marketing material review
- Regulatory authority liaison
Contact us today and we will be pleased to assist you with your regulatory compliance needs!