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.
Canada (Health Canada)
Strategy
- Regulatory Advice
- Medical Device Risk Classification
- Due Diligence and Gap Analysis
- Pre-submission Meeting
- Support during Agency Review
Management
- Post-Marketing Lifecycle
- Authorized Agent and Senior Scientific Officer
Writing/Review/Filing of Submissions
- New Drug Submissions (NDS, ANDS, SNDS)
- Prescription to Non-Prescription Switch
- Product Monograph and Mock-up development as per Plain Language Labelling (PLL)
- Risk Management Plans (RMPs)
- Master Files
- Drug Submissions Relying on Third-Party Data (SRTD)
- Medical Device Establishment and License Applications (Class II, III, IV)
- Drug Identification Number (DIN) Submissions
- Clinical Trial Applications (CTA)
- Natural Health Product Licence Applications (PLAs)
United States (Food and Drug Administration)
Strategy
- Regulatory Advice
- Due Diligence and Gap Analysis
- Pre-submission Meetings
- Support during Agency Review
Management
- Post-Marketing Lifecycle
- U.S. Agent
Writing/Review/Filing of Applications
- New Drug Applications (NDAs)
- Biologics License Applications (BLAs)
- Investigation New Drug Applications (INDs)
- Label development
- Risk Evaluation and Mitigations (REMS)
- Drug Master File (DMF)
- Medical device applications
Our Regulatory Affairs Leaders
Ruth Moses
Vice President, Quality, Regulatory & Safety
Mary Speagle, BSc., RAC
Senior Director, Regulatory and Scientific Affairs
Lisa Milton, BSc.,
Director, Chemistry Manufacturing & Control
Shirley Furesz, Ph.D., RAC
Director, Medical Devices
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.
Integrated Regulatory Services
Publishing & Submissions
bespoke services tailored to your individual requirements
Whether you are getting ready to submit for the first time and need help putting together a meeting request, or submission dossier, we can help. We prepare submission ready documents based on regional format requirements.
Device and Diagnostic Regulatory Solutions
Regulatory and Quality Assurance guidance
Senior consultants with years of experience and relationships working with Health Canada and the FDA. Areas of expertise for medical devices include; regulatory strategic consulting, license applications, publishing, post-marketing life cycle, regulatory writing, and quality.
Quality Assurance Consulting
navigate the ever changing world of quality compliance
From importation, routine quality oversight and quality system development, to audit mitigation, training and facility validation. Specializing in identifying effective solutions to complex problems. We can help you build a quality system that is right for you.
Canadian Regulatory Intelligence and Foreign Safety Updates
Training
We also offer group and individualized training in the following areas to meet your needs:
