3S Pharma
Contract research organization providing end-to-end clinical development and bioanalytical services from early-phase (including first-in-human) through Phase IV. Operates clinical research units and on-site bioanalytical laboratories with infrastructure for PK/PD, BE/BA and transdermal studies, regulatory support, clinical monitoring and AI-enabled clinical data collection. Publishes a detailed list of analytes quantified by mass-spectrometry and contributes to peer-reviewed pharmacokinetic and bioequivalence literature.
Industries
Nr. of Employees
small (1-50)
3S Pharma
No. 52 Sabinelor St., 050853 Bucharest, Romania
Products
Clinical Development Services
3S Pharma offers clinical development services, including early development clinical trials, focusing on safety, tolerability, and initial efficacy of new treatments.
Bio-Analytical Services
3S Pharma provides bio-analytical services with over 200 validated methods, analyzing more than 100,000 samples annually, using advanced equipment like mass spectrometers and robotic systems.
Clinical Centers
3S Pharma operates clinical centers in Romania and Moldavia, equipped for various study requirements, including long-term confinement and emergency facilities.
Transdermal Drug Delivery Systems
3S Pharma develops transdermal drug delivery systems, which administer medications through the skin, offering a non-invasive alternative to traditional methods.
Comparative Bioavailability and Bioequivalence Studies
3S Pharma conducts comparative bioavailability and bioequivalence studies, essential for the approval of generic drugs.
Clinical Development Services
3S Pharma offers clinical development services, including early development clinical trials, focusing on safety, tolerability, and initial efficacy of new treatments.
Bio-Analytical Services
3S Pharma provides bio-analytical services with over 200 validated methods, analyzing more than 100,000 samples annually, using advanced equipment like mass spectrometers and robotic systems.
Clinical Centers
3S Pharma operates clinical centers in Romania and Moldavia, equipped for various study requirements, including long-term confinement and emergency facilities.
Transdermal Drug Delivery Systems
3S Pharma develops transdermal drug delivery systems, which administer medications through the skin, offering a non-invasive alternative to traditional methods.
Comparative Bioavailability and Bioequivalence Studies
3S Pharma conducts comparative bioavailability and bioequivalence studies, essential for the approval of generic drugs.
Services
Full-service clinical trial support from study design and regulatory submissions to site operations, monitoring and final study reporting.
FIH study design and conduct with adaptive dose escalation, safety monitoring and in-house bioanalysis.
High-sensitivity bioanalysis using mass-spectrometry and immunoassays, method validation, high-throughput sample processing and traceable data reporting.
Custom PK and interaction studies with validated assays, NCA, statistical analysis and clinical study report preparation suitable for regulatory submission.
In vitro and in vivo adhesion testing, skin permeation studies and PK assessments for transdermal systems.
Risk-based, centralized, remote and on-site monitoring plus routine and for-cause audits, TMF review and audit-readiness support.
Full-service clinical trial support from study design and regulatory submissions to site operations, monitoring and final study reporting.
FIH study design and conduct with adaptive dose escalation, safety monitoring and in-house bioanalysis.
High-sensitivity bioanalysis using mass-spectrometry and immunoassays, method validation, high-throughput sample processing and traceable data reporting.
Custom PK and interaction studies with validated assays, NCA, statistical analysis and clinical study report preparation suitable for regulatory submission.
In vitro and in vivo adhesion testing, skin permeation studies and PK assessments for transdermal systems.
Risk-based, centralized, remote and on-site monitoring plus routine and for-cause audits, TMF review and audit-readiness support.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Early-phase and first-in-human studies
- Pharmacokinetics and PK/PD analysis
- Bioanalysis and mass-spectrometry quantitation
Key Technologies
- Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
- HPLC-MS/MS
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Ligand-binding immunoassays
News & Updates
Peer-reviewed publication reporting a single-dose comparative bioavailability study published in Frontiers in Pharmacology.
Peer-reviewed pharmacokinetic study of alverine citrate in healthy volunteers published in Frontiers in Pharmacology.
Publication describing use of medical infrared thermography to assess adhesive properties of buprenorphine transdermal patch formulations.
Clinical units and bioanalytical facilities inspected by FDA and multiple European national authorities with documented inspection outcomes.
Publicly available, detailed list of pharmaceutical compounds and metabolites routinely analyzed in biological matrices using mass-spectrometry methods.
Industry editorial award recognition noted on company site.
Peer-reviewed publication reporting a single-dose comparative bioavailability study published in Frontiers in Pharmacology.
Peer-reviewed pharmacokinetic study of alverine citrate in healthy volunteers published in Frontiers in Pharmacology.
Publication describing use of medical infrared thermography to assess adhesive properties of buprenorphine transdermal patch formulations.
Clinical units and bioanalytical facilities inspected by FDA and multiple European national authorities with documented inspection outcomes.
Publicly available, detailed list of pharmaceutical compounds and metabolites routinely analyzed in biological matrices using mass-spectrometry methods.
Industry editorial award recognition noted on company site.