Other Services:
Permitted Daily Exposure (PDE) Reports
Strategic reports developed to evaluate and manage cross-contamination risks in shared manufacturing facilities.
Development of Active and Inactive Ingredient Quantification Methods in Pharmaceuticals, Method Validation, and System Validation
Clinical Overviews & Summaries
Detailed assessments of clinical data for New Drug Applications or generics, prepared in accordance with EMA/FDA guidelines to evaluate risks across sensitive and general populations.
Non-Clinical Overviews & Summaries
Comprehensive reports integrating in vitro and in vivo data, strictly following EMA and FDA regulatory frameworks.
Excipient Risk Assessment
Toxicological evaluations of inactive ingredients, providing data-driven dosage recommendations tailored to age, weight, and specific pathological conditions.
Environmental Risk Assessment
Ecotoxicological reports analyzing the environmental footprint and potential ecological impact of pharmaceutical products.
Regulatory Dossier Preparation
Expert compilation of registration dossiers in the specific formats (such as CTD/eCTD) required by global regulatory authorities.
In Silico Toxicological Modeling
High-precision toxicity and ADME profiling utilizing Read-across, QSAR, and Swiss-ADME methodologies.
Phototoxicity Testing (OECD TG432)
Advanced in vitro assessment to determine the photosensitization potential of pharmaceutical compounds upon light exposure.
In Vitro Dermal Permeation (IVPT) Analysis
Specialized studies evaluating the skin absorption and penetration profiles of topical formulations.
Oral Absorption & Intestinal Permeability Testing
Comprehensive assays to determine the bioavailability and transport mechanisms of orally administered substances.
Abnormal Toxicity Testing
A critical in vivo quality control method, primarily for vaccines, utilized to detect hazardous biological contaminants.
Particle Size Analysis
High-precision characterization of molecular and particle dimensions using ZetaSizer or MegaSizer technologies.
Acute Toxicity Testing via Alternative Methods
Systemic safety evaluations conducted in strict accordance with OECD TG420, TG423, and TG425 standards.
Repeated Dose Toxicity Studies
Extensive safety profiling including Subacute (28-day), Subchronic (90-day), and Chronic toxicity/carcinogenicity investigations.
Genotoxicity Assays
Comprehensive DNA stability assessments featuring Comet Assay (OECD TG489), DNA Damage Analysis, Ames Test (OECD TG471), and HPRT Assay
Metal Analysis
Ultra-sensitive detection of elemental profiles and heavy metals utilizing ICP-MS or AAS instrumentation
Inflammatory & Anti-inflammatory Profiling
Quantitative measurement of prostaglandins, interleukins, cytokines, and chemokines via spectrophotometric and spectrofluorometric methodologies.
Oxidative Stress & Antioxidant Assays
Accurate determination of total antioxidant capacity, glutathione levels, and enzymatic activities.
Melamine Quantification
Highly sensitive HPLC-based detection of melamine in biological fluids, food, feed, and industrial products.
Bisphenol A, F & S Analysis
Determination of bisphenol analogues in products and biological matrices using HPLC or spectrophotometric techniques.
Phthalate Analysis (DEHP, MEHP, DBP)
Comprehensive testing of phthalate derivatives in various matrices via HPLC or spectrophotometric analysis.