Trac Services | Ad Hoc Regulatory Affairs Support | TRAC Services
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Ad hoc regulatory affairs support

The consultancy for global, pharmaceutical regulatory affairs

The background:

TRAC has been providing on-going ad hoc regulatory affairs support for this client for the past 10 years. The client, a UK generic affiliate for a global pharmaceutical company, has a large product portfolio focusing on pain, gastrointestinal, cardiovascular, central nervous system and anti-infective products.

The challenge

We help manage workload peaks, typically including:

  • Compiling and submitting variations
  • Interacting with the Medicines and Healthcare products Regulatory Agency (MHRA) including portal submissions
  • Updating summary of product characteristics (SPCs) and patient information leaflets (PILs)
  • User testing

The TRAC solution

Matthew Walker, TRAC’s Regulatory Manager, assesses the level of support required at any one time and allocates consultants who have worked with the client previously. Communication is through TRAC’s central system, with consultants having access to the client’s system and the capacity to request further information and queries. Both are updated and monitored regularly, as are timing estimates for each activity. Submissions are made by TRAC via the MHRA’s portal, on behalf of the client and confirmed with the client once submitted.

Matthew provides the client with a weekly report recording consultant-hours delivered against specific activities. All activities are then subject to our internal review process.

The outcome

TRAC’s flexible resource integrates seamlessly with the client’s internal processes and provides an economical solution to the lifecycle management of the client’s UK product licences.

The client’s ability to call on a team with which it has an established working relationship creates additional capacity and ensures continued revenue flows from its existing product licences in the UK.