i3 CanReg Inc.

Description

i3 CanReg Inc. provides regulatory affairs consulting services. It offers regulatory assessments and strategy development services; and chemistry, manufacturing and controls, and quality services, including GMP audits and training, the development and assessment of GMP quality systems, product/batch release, preparation of quality agreements, preparation for regulatory agency inspections, stability protocol preparation, analytical validation review, process validation protocol and report review, packaging qualification protocol and report review, supplier/subcontractor qualification, and the preparation of validation master plans. The company also provides pharmacovigilance services, including serious adverse event reporting to regulatory agencies, trial and post-marketing, review of safety processes and safety report management, preparation of standard operating procedures, coding of medical terms, preparation or review of periodic safety update reports, preparation for regulatory agency inspections/audits, and assisting in preparation of drug safety exchange agreements; medical writing; regulatory operations services, including electronic and paper publishing; and training courses and Webinars. It offers its services in oncology, gastroenterology, neuropharmacology, cardio-renal, metabolic/endocrine, special pathogens, anti-inflammatories/analgesics, and ophthalmology therapeutic project areas. The company serves venture capitalists, CROs, natural health product and food companies, cosmetic manufacturers, and governments. i3 CanReg Inc. was formerly known as CanReg, Inc. and as a result of its acquisition by Ingenix Pharmaceutical Services, Inc., its name was changed in December 2009. The company was founded in 1996 and is based in Dundas, Canada. As of December 3, 2009, i3 CanReg Inc. operates as a subsidiary of Unitedhealth Group, Inc.

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