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Regulatory Services

Navigate your product through the Regulatory Approval Process with TPIreg™

Our team of regulatory consultants was initially established by Anne Tomalin, as TPIreg™. With many years of experience and expertise in regulatory strategy, dossier authoring, submission preparation and lifecycle management, across multiple product categories. These services can be integrated with expert Publishing and Quality Assurance solutions. We will navigate your product through the complete regulatory approval process with Health Canada or US Food and Drug Administration (FDA). Offerings include, agency interface, pre-submission strategy, product classification, label development, common technical document (CTD) writing or review, support through to authorization post-market lifecycle management, advertising review, regulatory intelligence and training. Regulatory Services can be customized to fit your company’s needs.  

Regulatory Affairs

TPIreg™ provides Regulatory Affairs services for prescription and non-prescription pharmaceuticals and biologics, medical devices, combination products, natural health products, and cosmetics. The Regulatory Team includes members skilled in clinical/non-clinical, chemistry manufacturing and control (CMC), risk management, and labelling.

Our Regulatory Affairs Leaders

Anne Tomalin Anne Tomalin, BA, BSc, RAC
Vice President, Quality, Regulatory & Safety
Mary Speagle Mary Speagle, BSc., RAC  
Senior Director, Regulatory and Scientific Affairs
Lisa Milton Lisa Milton, BSc., 
Director, Chemistry Manufacturing & Control
Shirley Furesz, Ph.D., RAC
Director, Medical Devices
John Wong John Wong, M.Sc.Pharm,
Director, Regulatory Drug Advertising & Promotion

Unparalleled experience

Our team of experts have unparalleled years of experience and relationships working with Health Canada, the FDA, and quasi- regulatory bodies such as PAAB. Our team includes active members of global and local regulatory associations including DIA, RAPS, and CAPRA. TPIreg™ offers integrated services and customized solutions for innovator and generic products across the regulatory product lifecycle.


Training

We also offer group and individualized training in the following areas to meet your needs:

We can move your product forward and navigate your way through Regulatory Requirements.

Work with us Our integrated model