Case Studies

21Nov 2016

Recently, we were appointed by Bespak, a leading UK-based developer and manufacturer of complex medical devices, to provide GMP inspection readiness training ahead of their MHRA and FDA audits. Bespak supply respiratory drug delivery devices, valves and actuators, injectable devices and medical check valves into major European and US markets. Each year they assemble around […]

04Aug 2016

Shortly after opening our laboratory in 2013, we were appointed by a Dalkeith Laboratories, a UK-based, generic pharmaceuticals distributor to support them with their ongoing analytical testing requirements. This relationship continues to the present day. Here we explain some of the services we have provided them with and why they continue to work with us. […]

17Dec 2015

Sometimes even the best run pharmaceutical company needs a little helping hand to ensure that their quality systems are in tip top condition and that everything is squared away. Earlier this year we had the pleasure of working for Chiesi UK, a mid-sized pharmaceutical company confident in its systems but committed to ensuring all of […]

09Dec 2015

Celebrating Partnership and Success – and Cake. At Quality Context we get asked to assist with many pharmaceutical and healthcare compliance projects, both small and large. Recently, we received some exciting feedback from one of our clients entitled “The Proof of the Pudding”. Not an invitation to a Great British Bake Off style tea party, […]

10Sep 2013

Quality Context was appointed by a leading global pharmaceutical company to prepare and deliver Standard Operating Procedure (SOP) awareness training to its employees. The training was delivered across the company’s European operations. The Quality Context Ltd expert, who delivered the training, has over 15 years experience in the pharmaceutical industry, working with both large and […]

24Apr 2013

Quality Context provided IMP GMP training to a virtual pharmaceutical company and clinical trial Sponsor wishing to improve their Clinical Project Manager’s understanding of the GMPs required for manufacture and distribution of clinical trial products. Scope We were tasked with: Delivering a half-day training course to approximately twenty people with some understanding of the subject. […]

03Feb 2013

Quality Context was recently appointed by a leading global pharmaceutical company to redesign and help implement a new labelling system across their business which operates in over 80 markets around the world. Our core team included experts with detailed understanding of labelling legislation in key markets: Europe, North America, Australia, South Africa and ASEAN countries. […]

06Jul 2012

Quality Context provided Good Distribution Practice training to European distributor of Active Pharmaceutical Ingredients and excipients. The client wished to train new quality staff in the requirements of the updated EU GDP Guidance to allow staff to implement the required changes in legislation within the company. Scope We were tasked with: Delivering a one-day training […]

11Jan 2012

Quality Context provided development project management support and technical advice to a virtual pharmaceutical company wishing to develop a solid dose formulation with an Indian Contract Manufacturing Organisation. Scope We were tasked with: Providing technical guidance and troubleshooting advice for a tablet development project. Liaising with the client and the CMO on a regular basis […]

02Nov 2011

Quality Context was appointed by a leading global pharmaceutical company to conduct a world-wide programme of GCP audits as part of their ongoing supplier approval process. Our core team included auditors with expertise in GCP and experienced GCP project managers. Scope We were tasked with: Conducting a programme of audits to fulfill the requirements of […]

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