ToxLab R&D - Analysis, Reporting and Licensing Services
SERVICES
Analysis, Reporting and Licensing Services
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ToxLab R&D – Scientific Methodology and Expertise
Qualified Reporting and Advanced Analysis Solutions
By combining our industry experience with academic rigor, we generate highly accurate data in accordance with EMA, FDA, and TİTCK standards.
01
We prepare Clinical, Non-Clinical, and PDE (Permitted Daily Exposure) reports for original and generic products, ensuring full compliance with EMA and FDA guidelines.
02
We provide comprehensive safety reports for cosmetic products, including Systemic Exposure Dose (SeD) calculations based on NOAEL values and in-depth safety analyses.
03
We manage critical biocompatibility testing processes for medical device market authorization, integrated with ISO 10993 and MDR compliant technical file preparation and risk assessment reporting.
04
We conduct high-standard toxicity profiling, including Genotoxicity (Ames, Comet, and HPRT assays), Phototoxicity, and Acute/Chronic Toxicity analyses utilizing validated alternative methodologies according to OECD standards.
05
Utilizing Read-across, QSAR, and Swiss-ADME methodologies, we deliver high-precision toxicity and ADME predictions in a digital environment, optimizing processes prior to laboratory testing.
06
We provide ultra-sensitive quantification of critical impurities such as Melamine, Bisphenols (A, F, S), Phthalates, and Aflatoxins using advanced HPLC and spectrophotometric techniques.
Academic Expertise, Industrial Solutions
Your Reliable Solution Partner with Scientific Ethics and Global Standards
Operating within Hacettepe Teknokent, ToxLab provides qualified analysis and reporting services fully compliant with the regulations of the FDA, EMA, and TİTCK in the pharmaceutical, medical device, and cosmetics sectors, through its team of experts certified by the European Registered Toxicologist (ERT) and the American Toxicology System (ATS).
Analysis & Reporting
Regulatory
Product R&D
- ERT & ATS Certified Expert Team
- Qualified Toxicological Reporting
- Analytical Chemistry Expertise
- Product-Specific Scientific Approaches
- Integration of Academic Literature
- Reliable Data Analysis
- Full Compliance with FDA Requirements
- Reporting in Accordance with EMA Standards
- TİTCK Licensing Dossiers
- Global Regulatory Authority Compliance
- Comprehensive Process Management
- Regulatory Consultancy
- Pharmaceutical and Medical Device Solutions
- Cosmetic Product Safety
- Biocidal Product Analyses
- Process Improvement Recommendations
- Innovative Methodology Development
- Industrial Application Support