Update on InnomarClinics
InnomarClinics remain open to our patients amidst coronavirus (COVID-19) concerns.
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.
Canada (Health Canada)
United States (Food and Drug Administration)
Our Regulatory Affairs Leaders
Integrated Regulatory Services
Canadian Regulatory Intelligence and Foreign Safety Updates
Healthcare companies must stay informed of changes to regulations, guidances, policies, and regulatory information for pharmaceuticals and medical devices. Let us deliver the latest Canadian regulatory intelligence and foreign authorities’ safety updates to your inbox each week.
Training
We also offer group and individualized training in the following areas to meet your needs: