Specialized Studies &
Regulatory Dossiers
Turnkey analytical protocols designed to support international drug filings, bioequivalence clearances, container-closure safety, and stability shelf-life determination.
Extractable & Leachable (E&L) Studies
Comprehensive assessment of drug-container interactions for parenteral, inhalation, and ophthalmic products. Identifies organic and inorganic compounds that may migrate from packaging into drug products.
- Extractables screening via LC-MS/MS, GC-MS, and ICP-MS
- Leachables monitoring and correlation in drug products
- TTC-based toxicological safety assessment
- Analytical Evaluation Threshold (AET) & SCT calculation
- Full regulatory submission dossier support (USFDA, EMA)
ICH Stability Studies
Long-term, accelerated, intermediate, and stress stability studies for APIs and finished drug products. Supports shelf-life determination, regulatory submissions, and formulation development.
- Long-term stability (25°C/60% RH, 30°C/65% RH)
- Accelerated stability (40°C/75% RH)
- Photostability testing strictly per ICH Q1B
- Forced degradation & stress testing pathways
- Statistical shelf-life regression analysis per ICH Q1E
IVRT & IVPT Studies
In-Vitro Release Testing (IVRT) and In-Vitro Permeation Testing (IVPT) for topical semi-solid products. Supports bioequivalence studies, SUPAC changes, and formulation optimization.
- IVRT using validated synthetic inert membranes
- IVPT utilizing dermatomed human cadaver skin
- Automated Franz diffusion cell methodology
- f2 similarity factor mathematical analysis
- FDA SUPAC-SS Level 1, 2, and 3 change compliance
Elemental Impurity Studies
Risk-based assessment and testing of 24 elemental impurities in pharmaceutical products per ICH Q3D. Covers all routes of administration with appropriate Permitted Daily Exposures (PDEs).
- Screening & quantification of all 24 ICH Q3D elements
- High-sensitivity ICP-MS for sub-ppb detection levels
- Risk assessment adhering to ICH Q3D decision tree logic
- Permitted Daily Exposure (PDE) evaluation across all routes
- Full method validation conforming to USP <233>
Nitrosamine / NDSRI Studies
Highly sensitive detection and quantification of small molecule nitrosamines and NDSRIs in APIs and drug products. Supports FDA/EMA nitrosamine risk assessment and control strategy development.
- NDMA, NDEA, NMBA, NIPEA, NDIPA, NDBA & NMOR detection
- Custom method development for drug-specific NDSRIs
- Sub-ppm and ppb quantification via high-resolution LC-MS/MS
- Acceptable Intake (AI) limit comparison & CPCA scoring
- Comprehensive control strategy development support
Dissolution Profiling Studies
Comparative dissolution profiling, multimedia dissolution, and method development for solid oral dosage forms. Supports bioequivalence submissions, SUPAC changes, and biowaiver applications.
- Comparative dissolution profiling (CDP) for generic approval
- Multimedia dissolution profiles (pH 1.2, 4.5, 6.8 & biorelevant)
- Automated f1 and f2 similarity factor calculation
- BCS Class-based biowaiver submission study packages
- USP Apparatus I (Basket), Apparatus II (Paddle), and IV (Flow-through)
Need a Custom Study Protocol?
Our doctorate-led scientific team develops customized extraction profiles, stressed degradation pathways, and specialized bioequivalence protocols for non-compendial and complex molecules.