Draco's regulatory affairs consultants have helped dozens of clients secure regulatory approval, and maintain compliance, for hundreds 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:

• Natural Health Product License Application
• Natural Health Product Site License Application
• New Drug Submission
• Supplemental New Drug Submission
• Notifiable Change
• DIN Registration

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.