Laboratory Services

These laboratory services offer comprehensive analytical and formulation support spanning pre‑clinical through post‑approval stages. Advanced laboratories and experienced scientists provide method development, optimization, validation, and testing for raw materials, intermediates, APIs, and drug products. Modalities include small molecules, peptides, proteins, oligonucleotides, and cell and gene therapies, ensuring broad applicability across modern therapeutic categories. Capabilities extend to solid‑state characterization, impurity identification, structural analysis, extractables and leachables, elemental impurities, microbiology, and stability studies.
GMP analytical laboratories are designed for efficiency, featuring electronic laboratory notebooks and integration with formulation development, project management, and quality systems. Formulation teams support programs from compound to clinic, addressing complex formulation challenges, improving bioavailability, developing prototype dosage forms, and conducting compatibility, comparator, and lifecycle management studies. Services also include accelerated early‑phase development, pediatric and preclinical formulations, injectable prototype creation, QbD‑based development, and technology transfer. This integrated approach helps ensure product quality, regulatory readiness, and successful progression from discovery to commercial dosage form design.
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