Synth-Isis

Synth-Isis provides strategic and operational consultancy services in chemistry manufacturing & controls (CMC) to emerging pharmaceutical and biotech companies. They advise on all aspects of pharmaceutical chemical process development from candidate selection to commercial launch, including process validation. Their expertise includes contractor selection/management, contract negotiation/drafting, technology transfer oversight, supply chain management, and compiling the chemistry section of regulatory dossiers for INDs/IMPDs. The firm has acted as CMC technical lead during due diligence meetings for clients. No direct clinical results as they are not themselves developing drugs.