Post by Jansat Labs

JanSat Labs Officially Received Establishment Inspection Report (EIR) Hyderabad, India. JanSat Labs, a premier analytical-contract research organisation, proudly announces that it has received Establishment Inspection Report (EIR), marking a major milestone in its global compliance journey. 🎯 Key Highlights US FDA Establishment Registration & FEI Number 3017524864 – confirming facility inspection and compliance with US FDA. Successfully completed over 800 validation projects, spanning multiple dosage forms and regulatory agencies, including US FDA, EMA, MHRA, Health Canada, and Anvisa. Expertise in trace-level nitrosamines analysis using LC‑MS/MS, position JanSat Labs as one of the few CROs in South Asia with such compliant capabilities. Founded in 2018 and headquartered in Hyderabad, Telangana, JanSat Labs is widely recognised as a global centre of excellence for analytical testing. Its USP includes: Full-service offerings: Method Development, Method Validation, Method Verification, Method Transfer, Forced Degradation, Stability Studies, and Release Testing for APIs, intermediates, excipients, and finished dosage forms. Analytical techniques: GC, HPLC‑UV/VIS, PDA, RID, HS‑GC, LC‑MS/MS, chiral analysis, dissolution, cleaning validation (per ICH Q7 and FDA guidance). Extensive dosage form coverage: tablets, capsules, suppositories, multiple injectable types, syrups, suspensions, ophthalmic solutions, and albumin‑bound nanoparticle & liposomal formulations. ISO and DCA accreditations and compliance with GLP / 21 CFR Part 11 validated systems. With official FDA EIR , JanSat Labs can now serve as a trusted analytical partner for regulatory submissions to the FDA and other agencies. Enhanced Method Capabilities for Impurities The lab’s validated nitrosamine and genotoxic impurity workflows (e.g., NDMA, NMBA, NDEA) align with FDA and ICH M7(R2) standards, offering ultra-trace detection capabilities crucial for manufacturing compliance. Audit‑Ready Quality Infrastructure JanSat’s compliance with international inspection standards, including documentation, data‑integrity controls, and validated LIMS/21 CFR Part 11 systems, ensures smooth regulatory review. The lab provides holistic assistance—from Feasibility studies, and Method Development / Validations to method transfer and release testing—in a single integrated workflow. The awarded US FDA Establishment Inspection Report certifies that JanSat Labs has undergone a comprehensive site inspection by US FDA - a testament to its robust quality assurance systems and operational integrity. Jansat Labs has grown to support a diverse international clientele with complete analytical support aligned to global standards. JanSat prides itself on compliance, advanced instrumentation, and a deep analytical skillset spanning small molecules, biologics, and novel dosage forms.