Having worked for many years in the pharma industry, we are very experienced in leveraging cross-functional teams of formulation scientists, process engineers, statisticians and data management specialists. As a consequence, at Protea we can support, monitor or manage complete product development projects. You can use our expertise in:
- Formulation Development;
- Process Development;
- Product Process Improvement;
- QbD / PAT;
- Process Characterisation and Control;
- Process Validation.
Protea can offer complete project management solutions through extensive knowledge and (hands-on) experience in product development.
We can support, monitor or manage complete product development projects. We can provide you with a product development road map and successfully guide your product development to clinical proof of concept for EU-based submission.
We can also guide you through the requirements of submissions in China. However, please do consider that regulations are in a phase of great change in this country, and it might not always be possible to obtain straightforward advice.
Transparency is one of our main values: you select the best approach that fits your needs. Protea has no private laboratories or facilities for product development, production or analyses. We can recommend you the CRO or CMO that best fits your needs.
Protea has no financial interests in any company and provides a completely objective recommendation.
