Regulatory & Compliance

Over 481 Drug Master Files in Common Technical Document (CTD) and/or electronic (eCTD) 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 57 countries covering more than 127 APIs. Our jurisdictional knowledge and coverage include Canada, United States, Australia/New Zealand, European Union, Latin America (Brazil, Mexico), Middle East (Saudi Arabia, GCC), South East Asia (Malaysia, Singapore) and East Asia (Taiwan, Japan, China) among others.

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.