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Regulatory Dossier Conversion, Preparation and Submission

Licensing Routes

Pharmaceutical products can be registered in the EU using a number of procedures, dependent on the type of drug and the intended route to market. European legislation provides for a centralised procedure (CP), national registration route or decentralised European procedures – Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP).

The European legislation is enacted into UK law, however with the exit of UK from the European Union, for new licence applications, the UK can no longer take part in these European registration procedures.

More information on this is provided in Regulink’s Brexit insight.

Regulink offers European, national (UK) and International filing proficiency, covering the following licensing routes:

  • Marketing Authorisation Applications (all legal bases) via CP, MRP, DCP, National procedures, as applicable
  • Line Extensions
  • US Registrations – NDA, ANDA, BLA
  • International (ROW) Registrations

Dossier Conversion

As well as filing new licence submissions, a service is offered to convert from old format ‘NtA’ to meet current eCTD requirements, whether it be an initiating eCTD sequence requirement (CAP conversion for UK market “grandfathering”) or the conversion of a dossier to enter new markets.

Assistance can be provided to those Organisations with older product lines yet to move to eCTD format. Note a company must have an appropriate validated document management system. Whether it be specific CTD sections as part of a change control or an entire dossier, including summaries and overviews, this conversion can be done in parallel with a full conformance quality assessment, to correct and mitigate any future regulatory drift from manufacturing particulars.

Dossier Preparation

Regulatory Writing is a skill set imperative to anyone working with a dossier conversion or preparation. A successful regulatory submission requires a comprehensive understanding of and compliance with the current regulatory regime, adherence to the expectations of the Competent Authorities (which is not always harmonised) and the need for correctly presented and formatted information. Regulink has extensive experience in the preparation of the eCTD. The involvement of Subject Matter Experts can also be necessary, which is made available through our consultant partner network.

Dossier Submission

Regulink has significant experience with the UK and most EU competent authorities to appreciate the subtle differences in their expectations and requirements, so that applications will pass through this stage uninterrupted.

A successful submission needs to first pass through a content and technical validation step, it is therefore essential to get this right since invalidation can cause unnecessary and costly delays.

Amongst other aspects, our teams will diligently undertake the following critical regulatory operations for all dossier submissions:

  • Authoring of Local Administrative Requirements for CTD Module 1
  • CTD Modules 2-5
  • Management of eCTD publishing (using external vendors or client resources)
  • Acting as Applicant
  • Handling of submissions on Health Authority portals (using own or client accounts, as preferred)

Quality Promise

Regulink understands that of paramount importance in achieving right-first-time submissions and prompt approvals, is the quality of the submission documentation. In addition to being in compliance with regulations and guidelines, packages must be comprehensive yet succinct, expertly considered in all aspects of content and written to the highest professional standards. Regulink has decades of experience in the authoring and assembly (including publishing) of global regulatory submissions covering most product types and market regions. Additionally, we have deep experience in working with and acting as liaison with Health Authorities, or local subsidiaries or representatives, to ensure Competent Authority divergent and sometimes challenging expectations are always met.

Case studies

Showcasing our expertise with local/regional information and all modules of the eCTD, from product information to clinical, to expert summaries and non-clinical, and of course CMC. Connecting our clients to our network of partners and recommended suppliers, where needed, is a welcome add-on for many and is something we are proud to be able to offer at no obligation.

See our case studies →

OTHER REGULATORY AFFAIRS SERVICES

Whether it be a special regulatory project, intelligence, strategy or support with the essential life cycle management aspects, Regulink provides solutions that have delivered successful and cost-effective outcomes time after time. We are proud of the range and quality of services that we can provide, evidenced by the long term working partnerships we have established with our varied client list.

Licence Maintenance & LCM

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Active Pharmaceutical Ingredients – DMF & CEP

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Regulatory Strategy & Intelligence – Marketed Products

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Special Regulatory Services

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