📐
Analytical Method Development & Validation
Method development, transfer and full validation per ICH Q2(R2). Linearity, precision, specificity, robustness and accuracy — complete validation package.
ICH Q2(R2)HPLCUV-VisMethod transfer
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Impurity Analyses
Related impurities, degradation products and reaction monitoring. Impurity profiling and reporting at API and finished product level under ICH Q3A/Q3B.
ICH Q3A/Q3BHPLCDegradation products
⚠️
Nitrosamine Impurities Analysis
Nitrosamine risk assessment, determination and reporting under EMA/409815/2020 and ICH M7. LC-MS/MS analysis of NDMA, NDEA and other N-nitrosamine compounds. TİTCK-compliant format.
ICH M7EMANDMALC-MS/MS
📊
Rheological Tests
Viscosity profiles, flow curves and viscoelastic measurements (G'/G''). Comprehensive rheological characterization for semi-solid formulations; temperature sweep and thixotropy analyses.
ViscosityG'/G''Semi-solidThixotropy
🌡️
Stability Tests
Real-time and accelerated stability studies under ICH Q1A(R2). Stress testing (thermal, hydrolytic, photolytic, oxidative), photostability (ICH Q1B) and freeze-thaw cycles.
ICH Q1A(R2)ICH Q1BAcceleratedStress test
⚗️
Physicochemical Characterization
Comprehensive particle and structural analysis by FTIR, UV-Vis, NMR, XRD, TEM/SEM and AFM.
FTIRNMRXRDTEM/SEMAFM
🧪
In Vitro Release Test (IVRT) – In Vitro Permeation Test (IVPT)
IVRT and IVPT studies with Franz diffusion cell for topical and dermal formulations. Evaluation of active substance release and permeation using synthetic and biological membranes.
IVRTIVPTFranz cellTopicalDermal
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Q3 Sameness (Microstructural & Physicochemical Equivalence)
Demonstration of Q3 microstructural sameness in dermal preparations under EMA topical generic guideline. Comparative rheology, particle size and morphology analyses.
EMA Q3Topical genericMicrostructureEquivalence
👃
Performance Tests for Nasal and Inhaler Preparations
Particle/droplet size distribution, delivered dose uniformity, spray pattern and plume geometry tests for nasal spray and inhaler systems.
Nasal sprayInhalerDose uniformitySpray pattern
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Formulation Development
Preformulation studies, excipient selection and compatibility testing, CTD 3.2.P.2 compliant pharmaceutical development report.
PreformulationCTD 3.2.P.2CompatibilityScale-up
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Physical and Quality Control Tests for Solid Dosage Forms
Hardness, friability, disintegration, content uniformity and dissolution (including comparative dissolution) tests for tablets and capsules.
DissolutionComparative dissolutionHardnessContent uniformity
🩺
Physical & Chemical Characterization and Biocompatibility Tests for Medical Devices
Physical, chemical characterization and biological evaluation of medical devices in accordance with ISO 10993 series and MDR/IVDR requirements. Consultancy in technical file preparation.
ISO 10993MDR/IVDRBEPChemical characterization
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Cosmetic Tests
Cosmetic product formulation development, safety assessment (CPSR), stability, efficacy and microbiological tests. Consultancy in product information file (PIF) preparation under EU Cosmetics Regulation and TİTCK notification.
CPSREU RegulationTİTCKStabilityPIF
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Preclinical and Clinical Research
Preclinical study design, protocol preparation and consultancy in clinical research processes. Study planning compliant with TİTCK and ICH E6(R2) GCP guidelines.
PreclinicalClinical researchGCPICH E6(R2)
📑
Regulatory Services
CTD Module 3 writing, regulatory strategy consulting, deficiency responses and technical report preparation for TİTCK and EMA submissions. New applications, variations and renewals.
CTD Module 3TİTCKEMAVariationDeficiency response
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Training Services
Industry-focused training programmes on pharmaceutical technology, analytical validation, stability, CTD Module 3 writing and regulatory affairs. Practice-oriented content backed by academic expertise.
TrainingCTDValidationRegulatory affairs