Our Analytical Services
From small molecules to highly complex biologics — end-to-end, regulatory-aligned testing across peptides, NBCDs, biosimilars, extractables, nitrosamines, and food safety.
From small molecules to highly complex biologics — end-to-end, regulatory-aligned testing across peptides, NBCDs, biosimilars, extractables, nitrosamines, and food safety.
We provide comprehensive analytical testing supporting drug substances and drug products from early development through commercial release. Our validated methods, ICH-compliant documentation, and multi-technique platform give pharma and biotech clients a single, reliable CRO partner for the full product lifecycle.
All analytical methods are validated per ICH Q2(R1) with complete audit-ready documentation packages — method validation reports, system suitability criteria, SOPs — ready for FDA, EMA, and CDSCO submissions.
We have deep scientific expertise in characterizing non-biological complex drugs (NBCDs) — iron carbohydrate complexes, liposomes, nanotechnology-based formulations — where sameness cannot be established by molecular structure alone. Our IVBE studies and iron paramagnetic characterization panels support generic and follow-on product regulatory filings.
NBCD characterization packages are designed to satisfy FDA Draft Guidance for non-biological complex drugs and EMA reflection papers on iron-based products. IVBE studies include physicochemical equivalence endpoints supporting 505(b)(2) and biosimilar-like regulatory pathways.
Our peptide characterization suite spans structural identity confirmation, purity and impurity profiling, higher-order structure analysis, and forced degradation stability — covering the full lifecycle from drug discovery through regulatory submission. We work with synthetic peptides, cyclic peptides, PEGylated peptides, and complex conjugates.
Peptide characterization studies are conducted in alignment with ICH Q6B, FDA Guidance on Peptide Drug Products, and EMA quality guidelines. Complete analytical data packages support INDs, ANDAs, and NDA submissions.
We offer comprehensive physico-chemical characterization for biosimilar development, comparability studies, and regulatory submissions. Our advanced analytical platform covers primary structure, higher-order structure, post-translational modifications, purity, isoforms, and stability — delivering the complete data package required for FDA and EMA biosimilar filings.
Biosimilar characterization studies are designed to fulfill analytical similarity requirements under ICH Q5E, FDA Biosimilar Guidance, and EMA Biosimilar Guidelines. Data packages support 351(k) BLA filings and full comparability exercises for post-approval changes.
Bioprocess-related impurities — introduced or generated during production of biologics and biotech products — require rigorous analytical characterization for process development, clearance studies, and lot release. We cover the full spectrum: HCPs, residual DNA, antibiotics, process additives, buffer components, and leachables from single-use systems, using ELISA, qPCR, LC-MS/MS, and SEC-HPLC.
Upstream Process Impurities
Buffer Components
Antibiotics (15+ compounds)
Process Agents & Catalysts
Testing strategies align with ICH Q11, ICH Q6B, and relevant FDA / EMA process-related impurity guidance. Data packages support BLA/NDA submissions and process validation reports.
Chemical compounds that migrate from container-closure systems, single-use assemblies, or manufacturing equipment into drug products pose patient safety risks. Our E&L program delivers protocol-driven extractables studies, AET-based leachable method development, stability leachable testing, and container-closure interaction studies — fully aligned with USP <1663>, <1664>, ISO 10993, and ICH Q3E.
E&L studies are conducted per USP <1663> and <1664>, ICH Q3E draft guidance, ISO 10993-18, and PQRI guidance for orally inhaled and nasal drug products (OINDP). Reports are structured for direct inclusion in CTD Module 3 dossiers.
Nitrosamines and Nitrosamine Drug Substance Related Impurities (NDSRIs) are highly potent mutagenic impurities requiring ultra-trace detection capability, compound-specific risk evaluation, and a science-driven control strategy. Our program covers volatile and semi-volatile nitrosamines, NDSRI identification and quantification, risk assessment, AI calculations, and full regulatory submission support aligned with FDA, EMA, and ICH M7.
All nitrosamine testing programs satisfy ICH M7(R1), FDA Guidance on Nitrosamine Impurities (2021), EMA Nitrosamines Q&A, and WHO TRS 1025. Methods are validated at sub-ppb levels with isotope-labeled internal standards to meet AI-driven detection thresholds.
Our food testing laboratory delivers comprehensive safety and quality testing for manufacturers, exporters, regulatory bodies, and retail brands. We cover the full spectrum — microbiological safety, chemical contaminants, mycotoxins, pesticide residues, allergens, GMO testing, vitamins, food additives, and shelf-life studies — using internationally recognized methods and advanced instrumentation.
Testing is performed against FSSAI standards, Codex Alimentarius MRL limits, EU Regulation 178/2002, FDA 21 CFR limits, and ISO 17025-aligned methods. Reports are suitable for export certification, retail compliance, and regulatory submissions.
Our scientific team is ready to design a tailored testing protocol for your compound, regulatory pathway, and timeline. Most projects receive a quote within 48 hours.