Chemi-Call Ltd

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May 17

Chemi-Call Ltd

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To Whom It May Concern,

I am writing to share my professional experience while working with Dave Rushton of Paradigm Shift Consulting, who was consulted to help us improve our GDP compliance at my company’s two WDA sites.

During the initial WDA license application, the SOPs and QMS implementation were outsourced to a third-party company which got us through the initial inspection. Since then we did not have a follow up inspection, and the third-party company had been liquidated. The SOPs, current practices and staff training needed updating to reflect new MHRA regulations and improve internal compliance.

Dave was recommended to us as being one of the best in the field and I had the opportunity to work closely with him over several weeks to get us back into shape. He quickly identified the areas that needed improvement and prioritized each task. He worked tirelessly in an extremely professional manner to ensure that all the systems were revamped and all staff fully trained. On top of this, our systems were set up in a way that can be maintained by any staff member in the future. Following Dave’s work with us, we successfully passed our MHRA inspection which would not have been possible without his guidance.

I have an extreme personal and professional respect for Dave, his depth of knowledge and work ethic. I still call him for advice and he is always willing to help where he can. Anyone that requires GDP consulting, auditing or training should be put in touch with Dave. He does not make unrealistic promises, however defines goals and works with you to meet your expectations. I honestly cannot endorse him enough and look forward to continuing our work with him in the future.

Dr Puja Shah

Head of Clinical Services,

RP Chemi-Call Ltd