SERVICES
Our GMP services support a broad range of partners across the pharmaceutical and biopharmaceutical value chain, including biotech and pharma companies, start-ups, CDMOs/CMOs, and academic institutions. We also collaborate with excipient, packaging, and medical device manufacturers. From early development to commercialization, we provide outsourced reliable analytical solutions, customized consulting, scientific expertise, and flexible support to help our clients accelerate projects and meet the highest quality and compliance standards.
DEVELOPMENT & VALIDATION
After Analytical Target Profile definition, we support the development and validation of GMP analytical methods for APIs and drug products, with specialized expertise in the identification and quantification of impurities. Our services ensure robust stability and quality control, supporting the generation of reliable data for regulatory submissions and dossier preparation.
STABILITY STUDIES
We assist our clients with comprehensive stability testing on APIs and drug products, including stress testing and detailed characterization of degradation profiles. Studies are performed under ICH-recommended conditions (5°C, 25°C/60% RH, 30°C/65% RH, 30°C/75% RH, and 40°C/75% RH) to support quality and stability assessment throughout both development and post-approval phases, ensuring robust data for regulatory submissions and lifecycle management. Different conditions and ASAP studies on demand
PRODUCT CHARACTERIZATION AND BATCH RELEASE TESTING
Based on our solid experience, we support our clients in physicochemical product characterization and batch release evaluation, performed in accordance with pharmacopeial monographs or validated in-house methods, including analytical method transfer when required as well as Preformulation studies / compatibility with excipients and Reverse engineering. We help ensure consistent quality and compliance for small molecules, macromolecules, and biotechnological products.
ISOLATION AND IDENTIFICATION
Drawing on our solid scientific expertise, we deliver isolation and identification of unknown impurities using advanced analytical techniques such as mass spectrometry (MS) and nuclear magnetic resonance (NMR), combined with enrichment strategies and preparative chromatography. We also perform laboratory-scale synthesis to generate reference standards, enabling accurate characterization, control, and regulatory compliance of pharmaceutical and biopharmaceutical products.
BIOTECH PRODUCTS
With extensive experience in biologics, we provide dedicated bioanalytical testing services for the characterization and quality assessment of biotech products, including proteins, peptides, oligonucleotides, and other complex biomolecules: Electrophoretic pattern, Molecular weight determination, Peptide map characterisation, Post-translational modifications, Immunochemical properties. Through state-of-the-art techniques and tailored methodologies, we enable detailed structural and functional analysis, impurity profiling, and comparability studies, supporting development, quality control, and regulatory requirements throughout the product lifecycle.
STORAGE
Through dedicated infrastructure and controlled environments, we offer secure storage solutions for APIs, drug products, and biotech materials. Our facilities are designed to maintain defined temperature and humidity conditions, ensuring product integrity, traceability, and full compliance with regulatory requirements throughout the entire storage period.
EXTRACTABLES & LEACHABLES TESTING:
We provide comprehensive studies on extractable and leachable compounds to support quality assurance and patient safety. Our services include analytical evaluations in line with PQRI recommendations and USP requirements, and ICH Q3E guidelines, as well as toxicological risk assessments for a wide range of applications, including orally inhaled and nasal drug products (OINDPs), parenteral and ophthalmic drug products (PODPs), topical formulations, bioprocess disposables, and single-use systems. We also perform pharmacopeial testing on containers and closure systems, supporting regulatory compliance throughout development and commercialization.
NITROSAMINES & PGIs TESTING
Building on our strong analytical expertise, we offer dedicated services for the development and validation of highly sensitive methods for the identification and quantification of nitrosamines and potential genotoxic impurities (PGIs). Our capabilities cover drug substances and products, excipients, and packaging concerns, ensuring accurate detection at trace levels. We support risk assessment, method implementation, and regulatory compliance in line with current guidelines, helping our clients ensure product safety and maintain control over critical impurities throughout the product lifecycle.
MICROBIOLOGICAL TESTS
We support our clients in comprehensive microbiological testing activities, covering both specified and unspecified microorganisms. Our services include development and validation of analytical methods, microbial identification, bio assay of antibiotics, evaluation of antimicrobial preservative efficacy, disinfectant efficacy studies, environmental monitoring, and assessment of the microbiological integrity of packaging materials, ensuring product safety and compliance with regulatory standards.
BIOANALYTICAL TESTING
With dedicated expertise in bioanalytical science, we support our clients in pharmacokinetic (PK) and bioequivalence studies in both preclinical and clinical settings. Our services include the development and validation of bioanalytical methods, quantitative analysis of drugs and biomarkers in biological matrices, as well as metabolite identification and laboratory-scale synthesis of metabolites. We provide reliable data to support drug development, regulatory submissions, and clinical evaluation.
