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Quality and Compliance - a Top Priority: QA - QC and Regulatory Affairs

 

Strengths of this department can be summarized as the follows:

A team of young, skilled analysts.

  • Up to date analytical techniques including:
  • Liquid chromatography
  • Ionic chromatography
  • Gas chromatography
  • Spectrophotometrical analysis
  • Potentiometric titrators
  • D.S.C.
  • P.s.d. determination (sieve, microscope, laser light scattering)
  • Polarimetry

Routine Quality Team meetings for evaluation and continuous improvement of the quality system.

Personnel training courses on cGMPs, safety issues, and current legislation concerning APIs.

 

 

Regulatory Affairs section in contact with Health Authorities; preparation and submission of DMF documentation.

Complete technical assistance to customers to support registrations world-wide.

FDA inspections since the late 70s