FivePharma partnered with a US-based pharmaceutical company seeking EU-focused auditing support, which expanded into a global project.
The team conducted extensive audits across the client’s supply chain, including substance suppliers, formulators, packaging houses, distributors, and contract laboratories in various global locations.
In 2016 we worked with the QA Manager at a US based pharma company looking for EU focused auditing support.
The FivePharma team conducted audits as requested by the client of its suppliers in both its authorised product portfolio and its clinical stage products. We audited;
We advised the client on registration matters, and QP matters as well as helping to assess the adequacy of CAPA resulting from the audits. What began as EU-focused audits, the project gradually became global.
As the company moved its candidates from the clinic into the authorised phase, FivePharma provided ancillary services in the areas of regulatory and QP. Our ability to audit across multiple regulatory standards from the EU to the US to India and China was also considered a unique selling point.
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