CMC Projects that Eviva Pharma are currently or have recently been working on include:

Phase 1 injectable oncology CMC projects.  Eviva Pharma are providing, pharmaceutical development, analytical chemistry, CMC IMPD preparation, general CMC consultancy, assistance with regulatory submission and technology transfer to support a UK virtual biotechnology company.

Pre-phase 1 diagnostic injection.  Eviva Pharma are providing analytical chemistry and API support for this biological conjugate for intravenous administration for a regulatory consultancy/virtual UK biotechnology company.

Phase 1 oral development (‘inflammatory indication’).  Eviva Pharma are providing formulation development consultancy to a UK virtual biotechnology company.

Established small molecule for a new clinical indication.  Eviva Pharma are providing CMC projects consultancy to this small UK company to support a technology transfer from an Asian to an EU manufacturing facility.

Phase 2 liquid filled hard gelatin capsule. Eviva Pharma are providing a critical overview of all CMC /pharmaceutical development activities for a UK biotechnology company.

Orphan drug.  Eviva Pharma are providing formulation and analytical development, strategic regulatory and CMC Pharma consulting services for this range of formulations containing a well –established natural product active for a UK company.

Report writing for a contract manufacturer for a complex oral solid dose scale-up project (Phase 3) including review of full range of technical manufacturing documents.

Phase 2 oncology injectable CMC support for a European virtual biotech company.

Phase 2 hard gelatin capsule. Eviva Pharma are providing formulation, manufacturing and general CMC consultancy for an established active ingredient being repositioned for a novel indication at a different dose from the innovator indication.

A more extensive list of anonymised CMC projects that Eviva Pharma have worked on is given on the Historical CMC Projects page.