Quality & Regulatory System

Quality unit is headed by experienced professional. We belive in the concept of Quality in Production. Quality systems are designed and implemented in the organization in line with the ICH Quality and other International cGMP standards. Quality Control unit ensures the quality of product and utilizes morden techniques of analysis like HPLC, GC, FTIR. UV etc

Pharmchem has a very strong Regulatory Affairs divison, which continuously works for Preparations & filing of Dossiers as per the country specific Regulatory requirments. With the firm Regulatory back up, we can provide a strong back intergration of DMG grade APIs to our Formulation customers,

Our Analytical Capabilites

21 CFR compliant instruments as follows:

  • Chromatography – HPLC and GC Spertrophotometry – UV/Visible and FTIR
  • Titrimetry – autotitrator, potentiometer
  • Polarimetry – variable wavelength polarimeter
  • Physical testing – MP, bulk testing, LOD
  • Stability Studies – environmental testing chambers
  • Analytical micro balance