Draco's regulatory affairs consultants have helped hundreds of clients secure regulatory approval, and maintain compliance, for thousands of products regulated by Health Canada and/or the U.S. Food & Drug Administration. We can assist with:
Regulatory Submissions
Preparation, filing, and follow-up of submissions for drugs, natural health products, radiopharmaceuticals, biologics, medical devices, and cosmetics including:
- New Drug Submission
- Natural Health Product License Application
- Natural Health Product Site License Application
- Supplemental New Drug Submission
- DIN Registration
- Medical Device License Application
- Notifiable Change
Medical Devices
Preparation and filing of Medical Device License Applications (Class II, III, and IV) and of Medical Device Establishment License Applications.
Clinical Trials
Preparation, filing, and maintenance of Canadian Clinicial Trial Applications for company-sponsored and independent investigator studies following clinical trial best practice methodologies.
Labelling
Preparation and review of multi-lingual product labelling for all product types.
Product Monographs
Development, preparation, and review & revision of product monographs.
For regulatory affairs consultants, experienced with Health Canada and the FDA, who can assist with advice or hands-on services, and/or can complete regulatory affairs projects from end-to-end, contact us.
