Mutual recognition

September 30, 2019
Mutual recognition
Did you know that under the MRA (Mutual Recognition Agreement) FDA and EMA will now accept each other’s inspections?

The US Food and Drug Administration (FDA) will now recognise the Good Manufacturing Practice (GMP) inspections of all 28 member states of the EU. The European Medicines Agency (EMA) has already arranged with the FDA that inspections carried out by the latter would not require re-inspection by the European authority.

Let us take the opportunity and remind you, that Clinmark’s experts and auditors possess broad expertise in performing and accompanying comprehensive audits of manufacturing sites, laboratories and storage facilities.

We offer our services, such as: collection and preparation of the application documents, perform any type of submissions to the Regulatory authorities and provide comprehensive support to our clients from start of the project until receiving GMP Certificate issued by relevant authorities.

We support our clients in: • Preparation of the manufacturing site and manufacturing documentation for GMP Inspection; • Communication with EMA/FDA responsible for conducting of inspection; • Comprehensive support of a manufacturer during preparation and initiation of GMP inspection by EMA/FDA until the GMP Certificate is obtained.

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