TPIreg understands the hard work and effort our Clients perform to get to the exciting point of submitting dossiers to the authorities. Whether you are gearing up to submit for the first time and need help putting together a meeting request or are ready to submit a Drug Application we can help.

Our Regulatory Operations department is flexible to our Clients needs and can offer a bespoke program depending on their individual requirements. Our aim is to help as much as is needed while respecting our Clients wishes. The list below give an idea of the types of activities we provide either as a full service or as individual activities.

TPIreg offers our Clients e-submissions services and can either provide the finalized electronic submission to our Client for them to submit or submit to the health authorities on their behalf. See below for some examples of the types of services we offer. If you would like to know more or request a service not listed feel free to get in contact with our friendly professional staff.

Publishing:
Word
  • Providing/creation of templates
  • Formatting of documents for future editing and easy conversion to PDF’s
  • Consistency checks
Adobe
  • Creation of fully compliant Submission ready PDF’s
  • Creation and audit of Hyperlinks, Bookmarks
  • Preparation of text recognized documents from Scans etc
Submissions:
eCTD
  • Advice, Creation, Conversion, Responses, Maintenance etc
  • Electronic Submissions over the Gateways
  • Electronic Submissions on Media to Agencies and/or Client as required
NeeS
  • Advice, Creation, Conversion, Responses, Maintenance etc
  • Electronic Submissions on Media to Agencies and/or Client as required
Other
  • Electronic Submission of Cosmetic Notifications
  • Creation of Electronic NNHPD Submissions
  • Electronic Submission to NNHPD (TPIreg is a registered Trading Partner)

To find out more about how our team at TPIreg can help you, please call us at 905-690-4343 or email us at .

Therapeutic Products Inc. (TPIreg) – a boutique Canadian consulting firm offering regulatory and quality assurance services to the pharmaceutical and healthcare industry in North America.