By combining QA, QC, GMP, regulatory affairs and technical expertise we can help you achieve a product registration that will be compliant.
Together we will also work to reduce the risk for time-consuming variation applications in the commercial phase.
You as the marketing authorisation holder (MAH) have the ultimate responsibility for how a medicinal product performs over its lifetime, its safety, quality and efficacy. This means that you have responsibilities in many areas of Good Manufacturing Practice (GMP) even if a third-party contract manufacturing organisation (CMO) is present.
Communication between the MAH and the CMO must go both ways to ensure that the legal responsibilities and quality of the pharmaceutical product are in good hands.
The MAH is responsible for communicating the information registered in the marketing authorisation to the CMO, so that the manufacturer stays compliant.
Furthermore, prior to the MA-registration the MAH should consider the registration strategy with respect to future plans such as market access and market expansion, which affect potential scale up and technology transfers.
Other responsibilities of the MAH are:
ASMF (Active Substance Master File) and CEP (Certificate of suitability to the monographs of the European Pharmacopoeia) registration
Product Quality Review (PQR)
Complaints and product recalls
MA-variations
Maintenance of supply of medicinal products
At Arex Advisor we combine our extensive knowledge within GMP with technical expertise, CMC and regulatory experience to help you build a compliant dossier and sustainable product registration.
We can also support you with the compliance control of your CMO audits as well as offer advice on establishing an efficient system for knowledge transfer between MAH and CMO.
Acting Qualified Person (QP)
Auditing
Commercial production support and advice
Quality assurance and GMP compliance
Quality control and batch evaluation
Technology transfer support and advice
Nelly Fransén
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
