Accelerating Molecular Velocity through Advanced Analytics.
We are an FDA-registered analytical testing laboratory specializing in the rigorous kinetic evaluation and quality control of pharmaceutical compounds, from API synthesis to final drug product validation.
Our Mission
TLI Therapeutics is the industry-leading pharmaceutical and diagnostics company that aims to establish positions in large and rapidly growing medical markets by leveraging our discovery, development, and commercialization expertise and our novel and proprietary technologies. We intend to leverage our global commercialization expertise to pursue acquisitions of commercial businesses that will both drive our growth and provide geographically diverse sales and distribution opportunities.
Rigorous Analytical Vectors
Our validated methodologies cover the full lifecycle of drug development, ensuring compliance, purity, and efficacy at every stage.
Method Development & Validation
Establishing and validating novel analytical procedures (USP/ICH/FDA compliant) for complex matrices and trace impurity analysis, ensuring robust and reproducible data generation.
View Validation MatrixStability & Degradation Studies
Executing accelerated and long-term stability protocols (ICH Q1A-Q1F) to define shelf-life, characterize degradation pathways, and quantify related substances with high fidelity.
Define Stress ProtocolsManufacturing QC & Release
Providing critical quality control testing (finished product release, raw material analysis, excipient verification) under stringent GMP guidelines to ensure batch conformity.
Explore QC FrameworkThe TLI Kinetic Assurance Pipeline.
We integrate state-of-the-art instrumentation with highly credentialed Ph.D. chemists to provide data integrity that withstands the most rigorous regulatory scrutiny. Our four-phase process guarantees scientific precision.
- Full spectroscopic and chromatographic capabilities
- Dedicated dissolution and bioavailability modeling
- GxP compliant data archiving and reporting
Protocol Initiation
Define scope, required LOD/LOQ, and regulatory pathway alignment (FDA/EMA).
Analytical Execution
Chromatographic separation, quantitative mass spectrometry, and validation runs.
Data Integrity & Review
Internal QA/QC audits, statistical process control, and raw data verification.
Certificated Release
Final CoA (Certificate of Analysis) delivery and comprehensive report generation.
Regulatory Conformance
FDA Registration and Full GxP Compliance since 2012.
Uncompromising Data Sovereignty
Regulatory compliance is the bedrock of our operation. Our facilities, SOPs, and reporting structures are meticulously maintained to exceed FDA guidelines, minimizing risk in your development lifecycle.
21 CFR Part 11 Compliant
Secure electronic records and verifiable audit trails.
cGMP Framework
Quality systems supporting clinical and commercial release batches.
Initiate Kinetic Analysis.
Connect with our Principal Scientists to discuss your specific analytical challenges, timeline requirements, and project scope definition.
New Business Inquiries:
info@TLITherapeutics.comDirect Line:
(919) 746-8024Research Facility Location
TLI Therapeutics, LLC
One Park Drive
Research Triangle Park
North Carolina 27709, USA
Ph: 1 (919) 746-8024
European Operations
TLI Therapeutics, LLC
1 Portland Street
Manchester M1 3BE
United Kingdom
Ph: 44 (0) 161 394 1553