We offer third party audits for new and existing manufacturing facilities to ensure high quality standards which complies with GMP norms and acceptable by regulatory authorities.
Our services include:
– Preparation, Initiation and Management of GMP Audits from health authorities
– Third party/Supplier audit/EU QP audits/Mock audits
– Assistance to prepare Site Master File, Standard operating procedures and investigation reports for deviations.
– Response preparation for GMP deficiency report.
Scientific or Medical Monitoring review is a significant source of information for monitoring of the safety profile & of risk benefits of the medicinal product. Scientific Literature is mandatory to perform once your product is registered on ARTG.