About - GCC
Gencyst Clinical Center (GCC) is Finland based clinical facility, providing services for bioavalibility (BA) & bioequivalence (BE) studies, therapeutic equivalence, and phase-I clinical trials. GCC is offering advance and fully fully automated bioequivalence and clinical trial analysis of new and generic drugs (generics), give an expert assessment of their effectiveness and safety before launching into mass production.
The GCC is equipped with fully automated modern equipment, including mobile systems for monitoring the condition of participants (volunteers), has necessary operational licenses and quality assurance certificates.
GCC Laboratory has participated in more than 500 bioequivalence and pharmacokinetic studies. We are expert in detecting low molecular weight compounds in biological samples with high precision.
Benefits of working with us
- The company employs market experts, including candidates of pharmaceutical sciences.
- We publish the data of our studies in high impact factor journals.
- We regularly update SOPs – Risk Management ISO 17025 accreditation.
- We provide volunteers with the most comfortable conditions for their stay. We engage networking channel of GCC for volunteers systematic recruitment and regularly invite the target audience.
- We provide “One Window” operation services to our customer on all matters from study design permission – method validation up to drug registration.
- We will find a solution for your problems!
Quality Assurance
- Strict adherence to FDA & ICH quality compliance and bioanalysis SOPs.
- Regular training of staff on GLP, procedures, sample handling, documentation.
- GLP certification (GOST 33044-2014), ISO 9001:2015.
- Adherence to GCP, GCLP principles.
- Certification GOST ISO/IEC 17025-2019.
- Single integrated QMS and monitoring full chain of custody during storage.
- Preparedness for any customer audits, language translation facility.
- Risk-oriented approach in process management, business continuity management in accordance with BC/DRP plan.