Trac Services | On-Going Management Of Client Regulatory Activities
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On-going management of client regulatory activities

The consultancy for global, pharmaceutical regulatory affairs

The background

TRAC has worked with this medium-sized international branded pharmaceutical company since 2011. As its regulatory affiliate, we manage all regulatory activities for its product licences – 33 in the UK, 17 in Ireland and two in Malta.

The challenge

Working across the client’s product portfolio, typical activities include:

  • Compiling and submitting Marketing Authorisation Applications (MAAs) and variations
  • Interacting with agencies – Medicines and Healthcare products Regulatory Agency (MHRA), Irish Medicines Board (IMB) and Malta Medicines Authority, including portal submissions
  • Reviewing packaging, updating summary of product characteristics (SPCs) and patient information leaflets (PILs)
  • Writing clinical expert statements
  • Liaising with the client’s centralised regulatory team
  • Legalising and notarising certificates of pharmaceuticals product (CPPs)

The TRAC solution

We typically allocate the equivalent of one full-time regulatory consultant a month to this client. Mindful of the experience and expertise required, the workload is shared across six of TRAC’s consultants led by Graham Donaldson.

In a diverse and on-going management project of this kind we regard communication as key. Consultants liaise directly with their product manager partners and all activities are logged and updated centrally, and made accessible to everyone involved.

Graham uses TRAC’s internal professional automation software (PAS) to monitor progress and ensure deadlines are met. Meetings are held fortnightly to discuss progress and work management schedules.

The client receives quarterly progress reports and Graham attends quarterly meetings with the client stakeholders. In addition, Graham arranges at least one face-to-face meeting each year as well as attending the client’s annual company conference.

The outcome

The client benefits from an experienced and effective resource dedicated to the lifecycle management and product development of its UK, Irish and Maltese product licences.

TRAC’s provision of a long-term regulatory solution offers the client consistency, well-established working patterns and increases client in-house regulatory capacity.