Development Services

FineTech also offers chemical process development and custom manufacturing for complex high value molecules required for toxicology/clinical investigations, formulation development and drug product manufacturing.

We offer synthetic route identification, process development and scale up, under cGMP for new and established drugs required for toxicology, clinical investigations, formulation process development and ultimately drug product manufacturing.

Where a client has an existing chemical synthesis our chemists can utilize this as the starting point for development and scale-up.
We also offer assistance in preparation of comprehensive product dossiers (technical packages), regulatory documentation and Drug Master Files (DMFs)

Development Capabilities

  • Complex Multi-Step Custom Synthesis
  • Complete Literature and Patent Analysis
  • Polymorph Development and Identification
  • Process Scale-up
  • Analytical Method Development
  • Impurity Profile Determination

Regulatory and Quality Control

  • Drug Master File Preparation
  • Complete Batch Record Preparation
  • Real Time and Accelerated Stability Studies
  • Validation of Analytical Methods
  • Cleaning Procedure Development and Validation