04/02/2020 - Update on InnomarPharmacy and InnomarClinic hours and availability
InnomarClinics remain open to our patients amidst coronavirus (COVID-19) concerns.
Learn more.

TPIreg™ Regulatory Services

Navigate your product through the Regulatory Approval Process

TPIreg has a solid reputation, with expertise in all areas of Regulatory Affairs including; regulatory strategic consulting, marketing applications, publishing, post-marketing life cycle, regulatory writing, and CMC/Quality. TPIreg also provides Quality Assurance consulting services.

Unparalleled expertise

Our team of experts specialize in the areas of Gastrointestinal, CNS, Ophthalmology, Cardiovascular, Biosimilars, Rare Disease, Oncology, and Medical Devices. The senior consultants at TPIreg have unparalleled years of experience and relationships working with Health Canada and the FDA and quasi regulatory bodies such as PAAB. TPIreg is dedicated to offering Regulatory and Quality Assurance guidance and insight for the pharmaceutical, biotechnology, natural health product and cosmetic industries at each stage of the product lifecycle.
Two people collaborating with a laptop

Regulatory Services

TPIreg provides regulatory support to innovative and subsequent entry clients for pharmaceuticals, biotechnology and medical devices.

Canada

  • Strategic Regulatory Advice
  • Due Diligence and Gap Analysis
  • Clinical Trial Applications
  • Marketing Registrations (NDSs, DIN Applications, Medical Device Licence Applications, NHP Applications)
  • Post-Market Life Cycle Management
  • Publishing (eCTD and Nees formats through use of DocuBridge)

United States

  • Strategic Regulatory Advice
  • Due Diligence and Gap Analysis
  • INDs
  • Marketing Registrations (NDAs (505(b)(1) and 505(b)(2)) and ANDAs)
  • Post-Market Life Cycle Management
  • U.S. Agent Services
  • Publishing (eCTD format through use of DocuBridge)

Quality Assurance Consulting

Our team consults on quality assurance and GMP services for drug products, natural health products, cosmetics and veterinary products.

  • Importer of Record Services
  • Strategic Compliance Consulting
  • Full Commercial QA including Head of Quality designation
  • Manufacturing QA Support
  • Canadian QA Representation for Foreign MAH
  • On-site Support for Senior QA Positions
  • Representation during Health Canada Inspections
  • GMP, ISO Auditing Services
  • Medical Marijuana License Applications (growing & distribution)

Medical Device Regulations

TPIreg now provides a full suite of services for the medical device sector. Our team of experts have extensive experience with medical devices, in vitro diagnostics, companion diagnostics and combination products including those used in orthopedics, gastroenterology, general surgery, dermatology, gynecology, imaging, respiratory, ENT, urology, wound care, dentistry, infection control, and oncology.  
Learn about our Medical Device services

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 Affairs.

Work with us Our integrated model