Background

In 2012 the FivePharma team worked closely with the QA Manager at a UK based pharma company looking for EU focused auditing support.

Auditing services provided

The FivePharma team conducted audits of its suppliers to its authorised product portfolio. We audited distributors in Denmark, Portugal, Greece, Australia, the US, Australia and Hungary. 

While this company was developing additional medicinal products, we conducted audits of its clinical research organisation. 

Additional services

In addition, we provided training on self-inspection and delivered a 2-day programme, recurring every second year between 2012 and 2019. The client also needed help identifying a partner who could help them manage their EU Product Release requirements post-Brexit. This involved;

• Connecting them to one of our trusted partners
• Conducting some QP audits of their formulators to support QP Declarations and routine batch certification

As the company moved its candidates from the clinic into the authorised phase, we provided ancillary services in the regulatory and QP areas.

Why they chose FivePharma

Our ability to audit across multiple regulatory standards from the EU, Australia and the US was vital.  Recommending trusted partners to help keep their commercial activities running smoothly post-Brexit, was a real bonus.