Contact us

cmc-chemistry-manufacturing-controls-regulatory-strategy-support-impds-audit-of-manufacturing-processes

CMC Consulting

PX’ advises you on CMC aspects.
Multiply the chance of success for your projects!

 

 

You work on:

A soluble or insoluble protein or a peptide

Monoclonal or polyclonal antibodies

An antibody fragment

scFv, VHH, VH, Fab

Cells or microorganisms, natural or modified

 

CMC aspects – Chemistry, Manufacturing & Controls – are decisive for the ultimate success of a biological. PX’Therapeutics capitalizes on its experience and the expertise of its teams to offer its customers high-level CMC support.

 

 

Our goal


 

Boost the success of your biological by bringing you an effective regulatory strategy and operational assistance to implement it.

Our offer


 

 

  • Support in regulatory strategy.
  • Audit of the manufacturing and control processes that are already in place.
  • Proposals to improve the existing processes to make them more efficient, more robust and less expensive.
  • Advice on how to align the existing manufacturing and control processes with the new requirements.
  • Assistance in IMPDs drafting (Investigational Medicinal Product Dossier) and their submission to the competent authorities.

PX’ expertise in CMC Consulting