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

  • Advice, creation, conversion, responses, maintenance of INDs, NDAs, ANDAs, DMFs, NDS, ANDS, etc. 
  • Electronic submissions over gateways 
  • Electronic submissions on media to agencies and/ or client as required 
  • Request eCTD identifier numbers from agencies 
  • Management of Regulatory Enrolment Process (REP) 

NeeS

  • Advice, creation, conversion, responses, maintenance of CTAs, DINs, and medical devices license applications, etc. 
  • Electronic submissions on media to agencies and/or clients as required 
  • Management of Regulatory Enrolment Process (REP) 

SPL and XML PM

  • Create SPL and XML PM documents 
  • Create drug establishment registrations and no changes notifications SPLs 
  • Create drug/product listings and blanket no changes certification SPLs 
  • Create NDC labeller request SPLs 
  • Create GDUFA self-identification SPLs 
  • Convert Canadian PMs to XML PM 
  • Electronically submit SPLs and XML PMs

Public Release of Clinical Information (PRCI) 

  • Review and preparation of in-scope documents 
  • Redaction of personal and confidential business information 
  • Preparation of Anonymization Report 
  • Compilation and submission of both draft and final packages to Health Canada 

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/creating 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 and TOCs, editing in PDF 
  • Preparation of text-recognized documents from scans 

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 Canadian PMs to the 2020 template
  • Revision of inner and outer label mock-ups/artwork 

Our Regulatory Operations Leaders

Justin Evans

Justin Evans
Director, Regulatory Operations
Jacquie Denstedt

Jacquie Denstedt
Manager, 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.