Project Management
Complementary to your internal resources, we can provide consulting services in the form of complete Project Management for all your pre-clinical and clinical Chemistry, Manufacturing and Control (CMC) needs.
Our project management services consist of:
- Conceiving your chemistry development plan
- Preparation & forecast of manufacturing budget, analytical budget
- Contacting suitable service providers (manufacturing, analytical, formulation,...) and negotiate how best to execute your chemistry development plan according to your time lines and budget
- On-site audits
- Establishing chemical development and manufacturing protocols with providers
- Review of quality data (independent QA role)
- Preparation of the CMC section of your Clinical Trial Application.
We have established a network of consultants and service providers consisting of (chemical) engineers, chemists, pharmacologists and regulatory consultants. Our consultants have proven track records in academic and industrial settings.