Publishing & Submissions

Services tailored to your requirements

TPIreg understands the hard work, and effort, you perform to get to the point of submitting dossiers to the authorities. We help you get ready to submit for the first time, put together a meeting request, or submit a Drug Application. Our team prepares submission-ready documents based on regional and agency format requirements. We also keep on top of these submission changes, as they happen, so you don’t have to.

Submissions

Our team consists of highly experienced Regulatory Operations professionals with extensive experience specializing in Health Canada and FDA submissions.

eCTD

  • Creation and Validation Using Lorenz docuBridge/eValidator
  • Advice, Creation, Conversion, Responses and Maintenance of INDs, NDAs, ANDAs, DMFs, CTAs, DINs, NDS, ANDS, etc.
  • Request eCTD Identifier Numbers from Agencies
  • Management of Regulatory Enrollment Process (REP)
  • Electronic Submissions over Gateways

NeeS

  • Validation Using Lorenz eValidator
  • Advice, Creation, Conversion, Responses, Maintenance of CTAs, DINs, Medical Devices License Applications, etc.
  • Management of Regulatory Enrollment Process (REP)

SPL (Structured Product Labeling)

  • Drug Establishment Registrations and No Changes Notifications
  • Drug/Product Listings and Blanket No Changes Certifications
  • NDC Labeller Requests
  • GDUFA Self Identifications

Other

  • Comprehensive Print Production of Submissions
  • Electronic Submission of Cosmetic Notifications
  • Creation and Electronic Submissions to NNHPD (TPIreg is a Registered Trading Partner)

Publishing Solutions

MS-Word

  • Providing or Creation of Templates
  • Formatting of Documents for Future Use
  • Editing and Easy Conversion to PDFs
  • Consistency checks

Adobe Acrobat

  • Creation of Fully Compliant Submission-Ready PDFs
  • Creation and Audit of Hyperlinks, Bookmarks, TOCs, Editing in PDF
  • Preparation of Text-Recognized Documents from Scans, etc.

Datasets

  • Evaluate FDA Clinical and Nonclinical Research (SAS) Dataset Files for Compliance to Applicable Data Standards
  • Prepare ASCII Dataset Files for Health Canada Comparative Bioavailability Studies 
  • SAS to ASCII Dataset Conversion

Labelling

  • Convert US Product Information to SPL Format
  • Convert Canada Product Monographs to XML PM Format

Our Regulatory Operations Leaders

Justin Evans

Justin Evans
Director, Regulatory Operations
Jacquie Denstedt

Jacquie Denstedt
Manager, Regulatory Operations
Benny So

Benny So 
Associate, Regulatory Operations

Insight

Commercializing in Canada: Regulatory Publishing and Submissions


Innomar Strategies
April 2020

Looking to enter the Canadian or US pharmaceutical market? Ask us what you need to know about regulatory submissions. 

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