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PharSafer® understand the importance of being compliant and not only passing or ‘getting through’ audits and inspections but excelling in them; applying a constant quality improvement philosophy through the work of our White Gloves Audit Group, with over 75 years of senior auditor experience performing GCP and GPV audits against multinational legislation requirements, as well as 21 CFR Part 11/GAMP 5 audits on system validations. When forming a partnership with a client, we agree to see ourselves as an extension of their brand and Company ethos, protecting their reputation as we would our own, as we understand that any failures in compliance may result in significant consequences to their brand and to their product’s ability to produce revenue; guaranteeing that all standards of work are upheld to the highest possible standard, both within PharSafer® and in any external audits conducted.
PharSafer13Founded in 2003 by Dr Graeme Ladds, PharSafer® is a specialist Contract Research Organisation (CRO) in Global Clinical and Post Marketing Drug Safety, and Medical Services, with a wealth of experience in Pharmacovigilance, Auditing and Medical Affairs – and the various, numerous and extensive legal safety/medical obligations for licence holders to comply with – as well as Regulatory Strategy for the best methods for obtaining scientific advice concerning licence submissions and approvals. Together with our sister company which focuses on Training: SaPhar, PharSafer® continuously seeks new and innovative ways to provide added value for our global clients – going above and beyond expectations and optimising processes and procedures involved with clinical and post marketing drug safety and licencing approach. Our ability to offer first-class services in Pharmacovigilance, Regulatory Affairs, Training, Auditing, Medical Affairs and IT Informatics means that, for many clients, we operate as their Pharmacovigilance and Medical Departments – guiding them through the labyrinth of drug safety and medical legislation, all in the interests of ensuring patient safety and client compliance. We love what we do. We love finding solutions. Quite simply, we are by far... Your leading partner in Drug Safety.

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