Regulatory CMC
Technical advice and support
We provide CMC expertise and support related to manufacturing all the way from the early development phase to post-approval.
We provide CMC expertise and support related to manufacturing all the way from the early development phase to post-approval.
Working with us you will maintain a holistic view of all aspects of chemistry, manufacturing and control, while keeping the patient and treatment in focus.
Throughout the product lifecycle, we offer expertise for most types of formulations and indications and for chemical, herbal and biological products.
We provide expertise in all areas of CMC such as:
Active pharmaceutical ingredient (API)
Manufacturing process
Drug product formulation
Excipient selection
Analytical methods and method validation
Container closure and packaging
Stability
We help you mitigate risks and identify opportunities for CMC compliance from early development to post-market. Our specialists have extensive expertise in drug product formulation, manufacturing, and process development, as well as in analytical method development and validation related to the whole spectrum of drug products, for example:
More Regulatory CMC services:
CMC project management
CMC documentation
Formulation development and manufacturing advice
CMC strategies
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.