TPIreg | Therapeutic Products Inc. | Navigating Regulatory Affairs
Therapeutic Products Inc. is a company of Regulatory Affairs Consultants, founded by Anne Tomalin, BA, BSc. Regulatory Affairs. We are dedicated to North American Regulatory Affairs Consulting services for the pharmaceutical, biotechnology and natural health products industries.
We have the experience to assist with product development through to marketing applications and post-marketing activities and requirements.
With our many years of industry experience and our relationship with regulators, Therapeutic Products Inc., can move your product forward and help you navigate your way through Regulatory Affairs.
Our years of experience in Regulatory Affairs assist our clients with consulting and submissions to both the FDA and Health Canada for a variety of products and indications.
TPIreg understands the hard work and effort our Clients perform to get to the exciting point of submitting dossiers to the authorities. Whether you are gearing up to submit for the first time and need help putting together a meeting request or are ready to submit a Drug Application we can help.
Our staff provides quality assurance and Good Manufacturing Practices (GMP) services in order to conform to the guidelines recommended by government agencies for drug products, natural health products, cosmetics and food. Services include Importer of Record, release of commercial drug product to the Canadian market, and GMP audits.
Advertising & Promotion
Our team at TPI Reg offers consultation on advertising and promotional activities to help align with Canadian Advertising Codes and Standards such as PAAB/ ASC / Rx&D for Healthcare Professionals (HCP), Patients and Consumers Advertising of Prescription Drugs.
Our staff provides medical consulting services including Canadian Senior Scientific Officer for clinical trials, clinical input to drug development, due diligence and advertising reviews.