905.857.3132

info@regulatorysolutions.ca
Offering services, advice and assistance in relation to regulatory requirements.

Pharmaceutical Regulatory Affairs

Regulatory Solutions Inc., has obtained numerous new (branded) and generic drug approvals in the Canadian marketplace. Our team of associates will provide submission support during TPD reviews for all our Canadian and foreign clients in order to obtain a timely approval from Health Canada.

We provide a detailed review of your dossier and provide a comprehensive Gap Analysis to identify the gaps that need to be filled in order to successfully submit to Health Canada. Project management is our specialty and we will ensure that the project remains top priority and we work towards the quickest filing date.

As well, RSI routinely files provincial drug submissions and is very knowledgeable about the formulary requirements.

Pharmaceutical Regulatory Affairs