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.
- Assistance you during technical meetings with FDA & Health Canada.
We have established an elaborate network of consultants and service providers consisting of (chemical) engineers, chemists, molecular biologists (protein engineers), pharmacologists and regulatory consultants. Our consultants have proven track records in academic and industrial settings.