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
- organizational holdups
- geographical, and cultural gaps
- an immense load of documentation that must follow the regulatory requirements and allow for comparability between the processes to be established.
Why use our support with technology transfers?
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, among other things.
What is the result for you and your project?
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.