DRUG PRODUCT REGISTRATION
We prepare for filing to the:
- Therapeutic Products Directorate (TPD)
- Biologics and Genetic Therapies Directorate (BGTD)
- Veterinary Drugs Directorate (VDD)
We also assist companies in obtaining licences to sell their drug products.
Our services in this area include:
- Drug classification (labeling standard versus new drug, prescription versus non-prescription)
- Preparation of Drug Identification Number (DIN) applications
- Responding to Clarifaxes
- Preparation of compliant draft labels
- Filing notifications and amendments
- Filing Annual Drug Notifications
We prepare a full range of drug regulatory submissions for product licensing in Canada:
- Drug Identification Number (DIN-A)
- Drug Identification Number - Biologics (DIN-B)
- Drug Identification Number - Disinfectants (DIN-D)
- Drug Identification Number - Category IV (DIN-F)
- Low risk Veterinary Products application
- Administrative manufacturer name/product name change/licensing agreements (ADMIN)
Government cost recovery fees for drug applications can be expensive. You can ensure your application is right the first time with help from MEDERA.
Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.