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