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.
Regulatory Services
TPIreg provides regulatory support to innovative and subsequent entry clients for pharmaceuticals, biotechnology and medical devices.
Quality Assurance Consulting
Our team consults on quality assurance and GMP services for drug products, natural health products, cosmetics and veterinary products.
Training
We also offer group and individualized training in the following areas to meet your needs: