Qualified support should enable you to have smoother technology transfers, saving valuable resources and eventually bringing important medicines to patients faster.
This is where you might use help from Arex Advisor, a consultancy which can help pharmaceutical and biotech companies with technology transfer support and advice, among other things.
If you have a product in development, the need for a technology transfer will arise, sooner or later. It can be a matter of transferring between manufacturing sites or between different product stages, such as R&D, clinical or commercial.
The basic principle is simple, but with several technical, regulatory and business functions involved, there may be hurdles to overcome:
Technical challenges
Organisational holdups
Geographical, and cultural gaps
Documentation that must follow the regulatory requirements and allow for comparability between the processes to be established.
Arex Advisor can step in and assist you throughout the technology transfer process.
Our consultants are experienced in:
– Making risk assessments
– Performing regulatory and CMC gap analyses at the onset
– Guiding and overseeing the transfer from a QA, GMP, CMC or regulatory perspective
– Coordinating and handling specific parts of the transfer, such as regulatory submissions and CMC documentation.
In a few words, Arex Advisor is a consultancy which can help pharmaceutical and biotech companies with technology transfer support and advice.
Erik Hedner
Arex Advisor AB
Contact us
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.