Trac Services | Case Study: EU Standard CTD Dossier: Product Expansion
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Creation of European (EU) standard CTD dossier for a product’s global expansion

The consultancy for global, pharmaceutical regulatory affairs

The background

The consumer health division of a US-based global pharmaceutical company engaged TRAC on a global expansion project.

The challenge

To be delivered over a six-week period, the work centred on creating a EU standard CTD dossier of a US over the counter (OTC) Drug Monograph product for global expansion. The product came in three strengths and eight flavours.

The technical aspects of the project involved:

  • Gathering technical information from the finished product manufacturing site and API vendors
  • Advising on CTD requirements
  • Author Module 2 quality overall summary (QOS) and Module 3 of the CTD dossier
  • Reviewing clinical and non-clinical expert statements

The TRAC solution

This was our first experience of working for this particular client. As the time schedule was so tight, the project manager, regulatory affairs consultant, Lisa Pascoe spent the duration on-site with the client in the US. She was supported remotely by an associate with an experience of consumer health products.

Being on-site meant Lisa quickly built effective working relationships with all the client stakeholders. The project was continually progressed with her collating all the necessary information and passing it on to the associate consultant who authored the dossier.

Lisa visited the client’s manufacturing site to gather technical information; she was also able to offer specialist advice and guidance around the requirements for compliance of an OTC product outside of the US which has undergone a Marketing Authorisation Application (MAA).

The outcome

The client received an EU standard CTD dossier for global submission within a tight timeframe.

The client benefitted from the seamless integration of their in-house regulatory team with TRAC’s consultants, and the knowledge transfer of EU requirements and regulations.

Following the success of this project, TRAC has had further work from this client, with Lisa delivering regulatory affairs solutions working remotely from TRAC’s offices.