3S Pharma
Full-service Contract Research Organization (CRO) operating clinical research units in Romania and Moldova. Provides end-to-end clinical development and integrated bioanalytical services including early- to late-phase clinical trials, pharmacokinetics, bioequivalence/bioavailability studies, analytical testing (LC-MS/MS, ligand binding assays, ICP-MS), clinical monitoring and auditing, and data collection for machine learning. Facilities and processes have been inspected by international regulators and hold GLP/GMP-related certifications.
Industries
Nr. of Employees
small (1-50)
Services
Full-service protocol development, site execution, monitoring, data management and submission-ready reporting for interventional trials across all phases.
High-sensitivity quantitative testing (LC-MS/MS, ligand binding assays, ICP-MS) with validated methods and sample traceability.
Design and execution of PK/PK-PD and interaction studies including real-time PK sampling and biostatistical reporting.
On-site, remote, centralized and risk-based monitoring; routine and for-cause audits and medical monitoring to ensure GCP compliance and data integrity.
In vitro skin permeation, adhesion and irritation testing plus in vivo adhesion and PK performance studies for transdermal systems.
Design and analysis of observational cohorts, case-control and retrospective studies using medical records and other data sources.
Full-service protocol development, site execution, monitoring, data management and submission-ready reporting for interventional trials across all phases.
High-sensitivity quantitative testing (LC-MS/MS, ligand binding assays, ICP-MS) with validated methods and sample traceability.
Design and execution of PK/PK-PD and interaction studies including real-time PK sampling and biostatistical reporting.
On-site, remote, centralized and risk-based monitoring; routine and for-cause audits and medical monitoring to ensure GCP compliance and data integrity.
In vitro skin permeation, adhesion and irritation testing plus in vivo adhesion and PK performance studies for transdermal systems.
Design and analysis of observational cohorts, case-control and retrospective studies using medical records and other data sources.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Bioanalysis and validated analytical methods
- Pharmacokinetics and drug–drug interaction studies
- Bioequivalence and bioavailability studies
Key Technologies
- LC-MS/MS (HPLC-MS/MS)
- Ligand binding assays
- ICP-MS
- High-throughput bioanalysis
News & Updates
Profile article describing leadership, integrated CRO services, and regulatory inspection successes (FDA 2023, EMA 2024) and the company's integrated clinical and bioanalytical capabilities.
Clinical and/or analytical facilities inspected by the U.S. Food and Drug Administration with positive outcomes reported.
Clinical units inspected under coordination of EMA and national European agencies with inspections concluding in GCP compliance and data acceptance.
GMP certificate reported for the organization by the Romanian regulatory authority (certificate file referenced on site).
Analytical laboratory reported as GLP-certified with hundreds of validated bioanalytical methods and high annual sample throughput.
Profile article describing leadership, integrated CRO services, and regulatory inspection successes (FDA 2023, EMA 2024) and the company's integrated clinical and bioanalytical capabilities.
Clinical and/or analytical facilities inspected by the U.S. Food and Drug Administration with positive outcomes reported.
Clinical units inspected under coordination of EMA and national European agencies with inspections concluding in GCP compliance and data acceptance.
GMP certificate reported for the organization by the Romanian regulatory authority (certificate file referenced on site).
Analytical laboratory reported as GLP-certified with hundreds of validated bioanalytical methods and high annual sample throughput.