Jansat Labs

About Jansat Labs

JanSat Labs is a leading provider of analytical services, offering a comprehensive suite of services including Analytical Method Development, Method Validation, Method Verification, Method Transfer, Forced Degradation Studies, Stability Studies, and release testing for APIs, Intermediates, Key Starting Materials, and Excipients. We handle a wide range of dosage forms such as Tablets, Capsules, Suppositories, Injectable Suspensions, Liquid Injections, Lyophilized Injections, Albumin-bound Nanoparticle Lyophilized Injections, Liposomal Injections, PFS Injections, Syrups, Suspensions, and Ophthalmic Solutions. We provide unparalleled experience and expertise, leveraging the latest technologies, state-of-the-art laboratories, highly experienced technical staff, and a global network to deliver customized and innovative analyses. This ensures quality, safety, and compliance worldwide, with Method Validation data suitable for regulatory markets including US-FDA, MHRA, EMA, ANVISA, TGA, and KFDA. In recent years, our customized and innovative Analytical Method Validation data for Nitrosamine Impurities, Genotoxic Impurities (by LC-MS/MS), Assay & Related Substances (by HPLC), and Residual Solvents (by GC-HS) has been successfully filed by clients for US-FDA, EMA, and MHRA, receiving approval with zero queries. We have also assisted clients in successfully addressing regulatory inquiries from various authorities. Our strategy for Analytical Method Development employs sound scientific approaches, literature review, ICH guidelines, and regulatory requirements to develop robust and stability-indicative methods, which are crucial for ensuring product quality and facilitating faster regulatory approval. A dedicated project team can be assigned based on customer requirements. All equipment is installed in compliance with "21CFR part 11", featuring server-based systems and audit trails for both networked and standalone systems. We are FDA Registered with FEI Number 3017524864 and hold D-U-N-S Registration Number 86-134-3582. Our Services include: Analytical Method Development & Validation for Nitrosamine Impurities by LC-MS/MS. Analytical Method Development & Validation for Genotoxic Impurities by LC-MS/MS. Analytical Method Development & Validation by HPLC (RID, PDA & UV). Analytical Method Development & Validation by GC-HS. Assay and Related Substances Method Development and Validation. Dissolution Method Development & Method Validation by HPLC. Dissolution Method Development & Method Validation by UV. Forced Degradation and Photo Stability Studies. Stability Sample Analysis. Cleaning or Residue Method Development and Validation by HPLC and UV. Chiral Method Development and Validation. Analytical Method Transfer. Detoxification Method Development for potent drugs. Excipients Analysis by HPLC and GC as per the Monograph. Partial Method validations for Pharmacopeial Methods. Comparison Studies with RLD. DPDM Studies for Solid Orals. Infusion Studies for Injectables.