Bio-Analytic Studies
Precision in bio-analysis, excellence in data — advanced analytical services ensuring precise and reliable data for your research and development projects.
ISO 17025 Accredited Bio-Analytical Excellence
Bio-Analytic Studies are crucial for understanding the pharmacokinetics and pharmacodynamics of pharmaceutical compounds. At Omega Research, we pride ourselves on offering state-of-the-art bio-analytic services that meet the highest standards of quality and accuracy.
Our laboratory, accredited with ISO 17025, exemplifies our commitment to precision, reliability, and excellence in bio-analytic testing. This accreditation signifies our adherence to international standards, enhancing the credibility and acceptance of our data across global markets.
With a focus on maintaining the highest levels of accuracy and consistency, Omega Research supports stakeholders from drug development through to regulatory submission, providing critical data that informs decision-making and advances healthcare innovation.
Bio-Analytical Solutions
A comprehensive suite designed to support high-quality research and development across pharmaceutical and biotechnology companies.
Regulatory Strategy & Compliance
Robust strategies aligned with regulatory guidelines, ensuring bio-analytical studies meet all compliance requirements for FDA, EMA, and TİTCK submissions.
Advanced Analytical Methods & Validation
Cutting-edge analytical methods including LC-MS/MS, HPLC, and ELISA. All methods validated per ICH M10 and FDA Bioanalytical Method Validation guidelines for specificity, accuracy, precision, and stability.
Pharmacokinetic & Pharmacodynamic Analysis
Comprehensive PK/PD analyses offering insights critical for understanding drug behavior — including bioavailability, bioequivalence, dose-proportionality, and drug-drug interaction assessment.
Analytical Platforms & Capabilities
Application Scenarios in the Omega Ecosystem
How the Omega Research Ecosystem powers bio-analytic studies with ISO 17025 accredited infrastructure, kit standardization, and longitudinal PK sample management.
Omega Care
Home PK Sample Collection
Protocol-compliant home-based PK sampling for pre-dose and post-dose time points, enabling decentralized bioavailability and bioequivalence studies with reduced clinic visits.
Omega Genetics
Metabolomics & Biomarker Discovery
Untargeted and targeted metabolomic profiling, pharmacometabolomics integration with genetic data, and novel biomarker discovery for drug response prediction.
HelixLab
ISO 17025 Bio-Analytical Lab
LC-MS/MS and HPLC platforms under ISO 17025 accreditation with validated methods for small molecule quantification, biomarker assays, and immunogenicity testing.
Omega Bio
Kit-Based Assay Standardization
Diagnostic kit-based analytical infrastructure ensuring lot-to-lot consistency and cross-site methodological alignment for multi-center bio-analytical studies.
Omega Biorepository
PK Plasma Sample Archive
Serial PK plasma aliquots stored at -80C with complete chain-of-custody, enabling retrospective re-analysis, bioanalytical method bridging, and long-term sample integrity.
Animal Facility
Preclinical PK/TK Studies
GLP-compliant pharmacokinetic and toxicokinetic studies in rodent and non-rodent species, providing preclinical PK parameters to inform first-in-human dose selection.
Precision Bio-Analysis for Your Development Program
Partner with Omega Research for ISO 17025 accredited bio-analytical expertise.
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