QUINTA-ANALYTICA
Jan Chalupa is a highly experienced individual in the field of biotechnology and analytical chemistry. Currently working at QUINTA-ANALYTICA as the head of the validation team, Jan is responsible for developing, validating, and transferring analytical methods for pharmacological substances in bioequivalence studies. With a background in scientific research and technical work, Jan has a strong foundation in analyzing and documenting data for various studies. Jan's educational background includes a PhD in Biotechnology from the University of Chemistry and Technology in Prague, emphasizing their expertise in the field.
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QUINTA-ANALYTICA
Quinta is a GCP/GLP/GMP-certified, EMA and FDA-inspected European CRO offering in-house clinical testing, pharmaceutical analysis, CMC and R&D. Quinta specializes in clinical studies, bioanalytics, method development and quality control for both small and large molecules, human and veterinary IMPs as well as generics. We provide unrivaled expertise to worldwide pharmaceutical and biotechnological clients across the entire pharma spectrum. Quinta is part of the Conscio group with headquarters in Munich, Germany, laboratories in Czechia, Austria, Slovakia, Germany and offices in the USA. Our main service areas include: 1) Clinical Testing: With 2 in-house clinical units providing BE/BA/PK studies, with capacity for 60+40 beds. 2) Bioanalytical Testing: GLP/GCP solutions for preclinical & clinical studies, small & large molecules, BE/BA/PK. 3) Research & Development: Analytical R&D, impurities, extractables & leachables, degradation, trace studies. 4) Pharmaceutical Quality Control: GMP quality control, batch testing, stabilities, HAPIs, inhalation, API sourcing. 5) Microbiology: GMP sterile & non-sterile testing, microbial/water analyses, endotoxins, antibiotics & vitamins. 6) Biopharmaceutical Quality Control: GLP/GMP bioanalysis, CMC, characterizations of peptide & protein IMPs, biosimilars. Quinta was founded in 1997 and has been successfully inspected by FDA more than 10 times. Quinta is headquartered in Prague, Czech Republic.