Demonstrating our experience with product acquisitions:
A top five consumer healthcare company with operations in thirty five countries, contacted TRAC through our website. They sought regulatory support for four new product acquisitions to expand their portfolio. A regulatory strategy dealing with compliance matters was critical to securing the company’s continued sales growth in the EU.
- Perform due diligence on acquired product dossiers
- Remediate compliance matters from inherited historic dossiers
- Author updated CMC, clinical and non-clinical sections for four analgesic products with incomplete and outdated dossiers, compliant with the latest EU regulations
- Perform readability testing for the new product information
- Compile and publish the finalised dossiers in eCTD (electronic common technical document) format
- Submit the above as new decentralised (DCP) marketing authorisation applications (MAAs)
The TRAC solution
Regulatory Affairs Project Manager, Graham Donaldson led the project and was supported by two TRAC consultants with expertise in product acquisitions and due diligence. The initial project scope was to provide full EU regulation compliant CMC dossiers and to submit as new DCP MAAs in eCTD format. Full gap analyses of the historic existing dossiers (twenty five years and older) were undertaken and the regulatory strategy was discussed with the client’s product managers and the three current manufacturing sites.
As time was of the essence, the TRAC consultants held weekly teleconferences with the sites
to ensure that current manufacturing information was being gathered quickly and effectively. From this, TRAC authored fully EU compliant Module 3 dossier sections in line with current manufacturing processes. Throughout the project, the client was kept up to date on project progress.
Drawing on his lifecycle management experience, Graham introduced the use of document templates with appropriate levels of process, detail and authoring style. This initiative meant that the client no longer had to invest in excessive and unnecessary dossier section updates
when applying for post-approval variations, as recommended by the European Medicines Agency (EMA).
During the project it became apparent that clinical and non-clinical dossier sections were in need of updating. TRAC was able to provide expert knowledge to update both clinical and non-clinical documentation, meaning the scope of the project now entailed a full marketing authorisation dossier including CMC, clinical and non-clinical information. TRAC also ensured readability testing for the new product information was undertaken through our in-house product information expert.
TRAC eCTD published the final dossiers, using our in-house publishing software. TRAC made the submission via the Common European Submission Portal (CESP) and coordinated the delivery of any required hard copy documents.
The client received a completed EU standard Module 2 Quality Overall Summary, Non-Clinical Overview and Clinical Overview, Module 3, Module 4 and Module 5, authored to ensure ease of future life-cycle management. Each dossier was published in eCTD format by TRAC’s publishing specialists and submitted to all member states on behalf of the client.
With TRAC taking on all aspects of the project, the client had one point of contact, which ensured work could be streamlined by TRAC to meet strict timelines. It also ensured the client received consistency of information and detail across the four product dossiers. With TRAC managing all aspects of the project, the client was able to focus on servicing their busy, existing product lines. Its association with TRAC enabled this client to reap the long-term benefits of having life-cycle management initiatives in place that save them time and money in the future.