Regulatory Services

Pharmacist hands picking up pills

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

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.

Medical devices used in surgery

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.

Drug Advertising and Promotion Consulting

align with Advertising Codes and Standards

Helping you navigate through the various codes, guidance and policy documents to stay within Canadian Industry Standards, bridging your commercial and regulatory teams without compromising regulatory integrity.

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

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:

Compliance and GMP

Regulatory Affairs

Heath Canada Inspection Readiness

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

Close up of a meeting in progress