Trac Services | International CMC Compliance | TRAC Services
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International CMC compliance

The consultancy for global, pharmaceutical regulatory affairs

The background

A global pharmaceutical company came to us with an international Chemistry, Manufacturing and Controls (CMC) compliance project involving licences for 33 individual products across 16 brands within 10 markets in French West and Central Africa.

The challenge

This was a high volume project that was undertaken over a 12 month period.

The team’s work centred on a number of technical aspects, namely:-

  • Establishing what CMC information had been registered as part of the initial licence application and subsequent variations to the marketing authorisation.
  • Liaising with manufacturing sites to review CMC information for APIs and drug products and feedback deficiencies.
  • Compiling a full list of compliance gaps and performing risk assessments on the severity of compliance gaps.
  • Addressing compliance gaps.
  • Putting together fully site compliant CTD style dossiers and sending to markets for licence renewal submissions.

The TRAC solution

We assessed the project as requiring the equivalent of three full time consultants for its duration. The TRAC team, led by Matthew Walker, TRAC’s Regulatory Manager, distributed the workload across a team of five consultants hand-picked for their expertise and experience in the particular activities undertaken.

The team collaborated with a number of client stakeholders including manufacturing sites within the supply networks, quality assurance departments and local operating companies.

The work was broken down into smaller projects. Key milestones, leading to the overall deadline, were agreed for each of these. Matthew’s role focused on ensuring all deadlines were met, potential issues highlighted and addressed early on, and weekly in-house progress meetings held. As the lead contact he kept the client’s project sponsor fully updated.

The outcome

Successful delivery of over 70 product licence renewals within budget and within the 12 month time frame.

This saw the client benefit from continued revenue through the marketing of existing products in key regions, while maintaining good relationships with local agencies.

Working closely with a consistent dedicated team from TRAC created in-house capacity so that the client’s management and regulatory teams were able to concentrate on their core activities.

As part of TRAC’s commitment to continuous improvement of its service, Matthew led an internal project review to identify key elements that had worked well and also areas where improvements could be made.