We provide expert knowledge on the development of bio/pharmaceuticals with a special focus on CMC related issues.
We intend to provide a very broad and diverse service, with a deep understanding of the physico-chemical and immunological properties of innovative therapeutic moieties.
Services provided include:
- Analytical development and quality control
- Process development and transfer
- Writing and review of regulatory documents
(e.g.: SOPs, stability protocols, CTD sections )
- Development of quality specifications
- Communication with regulatory agencies
- Business development discussions
For more information please contact us by e-mail: firstname.lastname@example.org