Our team of inspectors can undertake audits to check for compliance with appropriate quality standards, including GLP, GCP, GMP, ISO 13485 and IS0 9001, as well as pharmacovigilance.
We have a team of inspectors to complete audits of facilities to check for compliance with the necessary quality standards applicable to both medicines and medical devices. Our consultants can advise on Good Laboratory Practice, Good Manufacturing Practice and Good Clinical Practice.
Once an official inspection by a regulatory authority has been scheduled we can complete a pre-audit. This uses the same criteria as a full audit and can help identify and resolve any issues that may lead to a negative outcome. Formal, detailed reports are provided for all inspections.
We can perform GMP audits of companies' own factories or those of contract manufacturers and GLP or GCP audits for CROs or other subcontracted testing facilities. For medical device companies, audits to ISO 13485, ISO 9001 or QSR can be undertaken.
We are able to conduct audits worldwide.