Since 2001, Regulatory Solutions Inc., has been a pharmaceutical regulatory approval/compliance consulting company with extensive success in obtaining Canadian regulatory approvals for prescription drugs, natural health products and medical devices.
Regulatory Solutions Inc., has a team of consultants, with a diverse set of skills, that have an excellent track record for obtaining Health Canada approvals in a straightforward manner that ensures the fastest time to approval. Many of our clients have been with us since the beginning. We treat each and every client (both small and large) with top priority. We consistently have repeat business from our globally diverse clients.
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.