Paul Madeley
Biography
Synth-Isis Ltd provides strategic and operational consultancy in CMC (chemistry manufacturing & controls) to emerging pharmaceutical and biotech companies.
We advise on all aspects of pharmaceutical chemical process development; from candidate selection to commercial launch, including process validation.
In addition to selecting suitable contractors, and assisting with contract negotiations and drafting, we can provide operational oversight and compile the chemistry part of the registration dossier.
We have acted as CMC technical lead in due diligence meetings on behalf of clients.
| Qualifications |
BSc PhD CSci CChem MRSC |
|---|---|
| Areas of Expertise |
Manufacturing People development Science, engineering and technology Strategy and policy |
| Services Offered |
Drug discovery Manufacturing and process development Regulatory, legal and compliance |
| Markets Served |
Biotechnology Pharmaceutical and medicinal |
| Geographic Regions Served |
UK Europe |
Contact Paul Madeley
Additional information
- Writing chemistry section of regulatory documents (IMPD and IND)
- Drug development
- Project management
- Procurement, contract negotiation and drafting, supply chain management
- Identification and management of contractors
- Technology transfer and management
- Synthetic route selection and strategy
- Compilation of CMC chemistry dossiers