REGULATORY AFFAIRS
To date, a total of over 500 Drug Master Files in Common Technical Document (CTD) format, have been prepared and filed by Apotex Pharmachem's highly qualified and experienced Regulatory Affairs team in all of the world’s advanced regulatory jurisdictions supporting marketing authorizations of all types of dosage forms. Our DMF submissions have been made in over 40 countries and to date cover approximately 100 different products. Some of the countries in which DMF submissions have been filed include:
- United States
- EU (EU Countries)- CEP/MRP
- Canada
- Australia
- Japan
Customer filings for marketing authorizations of pharmaceutical dosage forms
have been supported in virtually every market in the world.