Regulatory

Over 667 Drug Master Files in Common Technical Document (CTD) format have been prepared and filed by our highly qualified and experienced regulatory affairs teams 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 49 countries covering more than 118 APIs. Our jurisdictional knowledge and coverage includes the United States, EU (EU Countries) - CEP/MRP, Canada, Australia, Japan, Brazil, Russia, and China.

Our track record of enabling our customers’ marketing authorizations for pharmaceutical dosage forms, on schedule, into the world’s most stringent markets is your guarantee of our commitment.