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Laboratory for Pharmacokinetics and Clinical trials

Laboratory for Pharmacokinetics and Clinical trials

The laboratory for Pharmacokinetics and Clinical trials by the “Medical and Regulatory Affairs” Department has established its name throughout the years as one of the leading laboratories in the field of pharmacokinetic research and studies for bioavailability/ bioequivalence.

The laboratory is fully equipped, with extended capacity, with an implemented system according to Good Laboratory Practice (GLP) and complies with all current regulatory requirements.

Main activities and services:

  •  Time-critical development and validation of new methods in accordance with customer’s requirements:
           -    Medicines and Metabolites;
           -    Combined medicines;
  •   Assay of analytes in biological matrices;
  •   High volume sample analysis
  •   Study report writing
  •   As a part of the Medical and Regulatory Affairs Department at Sopharma, the laboratory offers:
            -    Complete BA/BE project management, pharmacokinetic studies;
            -    Regulatory submission and consultancy in compliance with the international standards.
  •   Our long-term partnership with leading Contract Research Organisations (CROs), scientific and research organisations and academic facilities enables us to provide a complete service for pharmacokinetic and bioavailability/ bioequivalence studies:
            -    Documents preparation;
            -    Study design;
            -    Clinical phase;
            -    Statistical analysis;
            -    Final study report.

The key advantages of the laboratory are:
  •   Highly qualified personnel;
  •   Conduction of all studies in compliance with the principles of GLP;
  •   Complex services with high quality and optimal prices.Нашата мисия : „Прецизна работа, надеждни резултати”.
Our mission: “Precise work, reliable results.”

Brochure in Bulgarian
Brochure in English