Regulatory Solutions Inc. (RSI), founded in 2001, obtains strategic and innovative Regulatory Affairs approvals from Health Canada in a time sensitive manner. We also assist in your company's post-marketing changes and provide excellent Good Manufacturing Practices (GMP) and Quality System services.
RSI continues to remain current with all Health Canada guidelines and regulations to achieve the highest efficiency in obtaining approvals. We are now operating in electronic CTD format (eCTD) for multiple submission types and have joined the pilot program for the Common Electronic Submissions Gateway (CESG) at Health Canada.
RSI has obtained numerous new (branded) and generic drug approvals in the Canadian marketplace. Our team of associates has also served clients in the United States, India, China, and Europe in obtaining Canadian regulatory approvals.
In addition, we have obtained Class II, III and IV medical device approvals as well as natural health products (vitamins, minerals).
RSI has set-up and administered several quality assurance systems and regulatory affairs departments for foreign companies that wished to locate to Canada. RSI has helped over twenty companies to obtain Drug Establishment Licences (DELs) for operations in Canada as well as chaperoned and supervised a variety of GMP audits by Health Canada of Canadian facilities.
In addition, we have represented several clients in due diligence matters concerning the licensing or sales of their approved pharmaceutical products to other manufacturers.
Since 2001, we have worked with the people at Health Canada as well as the local inspectorate- who are responsible for Good Manufacturing Practice audits for both pharmaceutical drug and natural health product importers and distributors.
Here is a list of Services that we provide:
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.
Regulatory Solutions Inc. provides time sensitive, strategic regulatory planning for Drug Identification Numbers (DIN) Applications and Natural Health Product Applications (Compendial and Non-Compendial). Our team will perform an extensive review and consult on the product labels based on the most current Health Canada requirements.
Prepare and provide submission support during Health Canada review for Class II, III and IV Medical Device Applications. In addition, we will confirm the risk-based classification and provide submission support during Health Canada review. As a part of our service, we will advise on any regulatory compliance issues which may be of concern during review.
Provide time sensitive and strategic consultation on compliance issues such as organizing and supervising compliance audits with the Health Canada Inspectorate from start to finish. We create detailed Standard Operating Procedures (SOP) and provide training in Good Manufacturing Practices (GMP). RSI has helped over 20 new companies obtain/renew Drug Establishment Licences, Medical Device Establishment Licences and Site Licences.