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Ensuring your internal systems or those of your supplier or client meet the necessary requirements is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.
How can we help?
Our consultants have all the necessary expertise and experience to complete audits of facilities anywhere in the world, checking for compliance with the necessary quality standards. We can advise on Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Clinical Practice (GCP). Audits can be performed in a company’s own factory or those of contract manufacturers. In addition we work in partnership with CROs and other subcontracted testing facilities, as well as undertaking audits to ISO 13485, ISO 9001 or QSR for medical device companies.
For further information on our Good Pharmacovigilance Practice (GVP) capabilities, follow this link: Audits & GVP
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION