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:
- Medicines and Metabolites;
- Time-critical development and validation of new methods in accordance with customer’s requirements:
- Combined medicines;
- Complete BA/BE project management, pharmacokinetic studies;
- 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:
- Regulatory submission and consultancy in compliance with the international standards.
- Documents preparation;
- 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:
- Study design;
- Clinical phase;
- Statistical analysis;
- Final study report.
The key advantages of the laboratory are:
Our mission: “Precise work, reliable results.”
- 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”.
Brochure in Bulgarian
Brochure in English