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 Health Canada 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 across Canada and is very knowledgeable about the various formulary requirements.