Worldwide BioMedEx Inc. was established in 1995 and specializes in project management /consulting services in the areas of regulatory affairs and quality & compliance – primarily for the animal health industry. Our expertise is provided in the areas of pharmaceuticals, biologics, feeds, pesticides and low risk (natural) health products.
With three managing partners and many associates worldwide, we are well-known to Canadian regulatory agencies and have a successful track record of product and facility approvals. Dealing with regulatory agencies on a daily basis ensures we are up-to-date on the latest “unpublished” requirements. We complement this information by participating in industry committees and bilateral workshops with regulators. Having a wide variety of clients also allows us to strategize alternatives/negotiations on many common issues to achieve registration and compliance.
A constant supporter of CAHI and its activities, particularly in strategies to improve efficiencies in the Canadian regulatory process and international harmonization, BioMedEx is active in both the Drug and Biologics Committees and participated in the Steering Committee for the interim “Low Risk Veterinary Health Products” notification program.