Our services: audits and product release
Article 41 of the Directive 2001/83/EC states that "In order to obtain the manufacturing authorization, the applicant shall […] have at his disposal the services of at least one qualified person within the meaning of Article 48."
At Mares Ltd., we provide experienced QPs for assessing Advanced Therapy Medicinal Products on behalf of our clients. Likewise, we provide QP services for releasing such products into the EU.
Inspecting the GMP compliance of biopharmaceuticals requires highly competent experts. Manufacturing authorization holders often need their Qualified Persons to be on-site, leaving little time to audit suppliers and contract manufacturers. To reduce their workload, EU GMP allows QPs to refer to third-party audits that have been conducted by other qualified auditors.
We at Mares Ltd. bring the necessary qualifications, experience and permits to do the job: On behalf of our clients, we conduct third-party GMP audits of suppliers and contract manufacturers of ATMP – so their own QPs don’t have to!
Medicinal products intended for clinical trials in the EU but manufactured outside of the EU require an import permit as well as an importing organization based in the EU.
An import permit is essentially a manufacturing permit for companies located outside of the EU, i.e. it is likely to bring about an inspection of the manufacturing site. The importing organization needs to release the product into the EU, hence requires a so-called Qualified Person (QP). At the same time EU regulations require a legal representative inside the EU in case of any legal repercussions.
Mares Ltd. obtains import permits on behalf of clients and provides QP services as well as legal representation services.
Beyond this, Mares Ltd. provides a comprehensive service package to clients e.g. interacting with authorities, hospitals, investigators, analytical facilities and so forth.