JanSat Labs is the world's leading Analytical services provider, we provide a complete suite of services like Analytical Method Development, Method Validation, Method Verification, Method Transfer, Forced Degradation Studies, Stability Studies and release testing for API, Intermediates, Key Starting Materials, Excipients wide range of dosage forms like Tablets, Capsules, Suppositories, Injectable Suspensions, Liquid Injections, Lyophilized Injections, Albumin-bound Nanoparticle Lyophilized Injections, Liposomal Injections, PFS Injections, Syrups, Suspensions and Ophthalmic Solutions.

We offer you unrivalled experience and expertise, the latest technologies, state of the art laboratories, highly technical experienced staff and a unique global network, as a result we can provide you customized and innovative analysis to ensure quality, safety and compliance anywhere in the world and the Method Validation data can be filed to Regulatory markets like US-FDA, MHRA, EMA, ANVISA, TGA and KFDA etc.

Over the past few years, our customized and innovative Analytical Method Validation (Nitrosamine Impurities, Genotoxic Impurities by LC-MS/MS, Assay & Related Substances by HPLC and Residual Solvents by GC-HS) data has been filed from various customers for US-FDA, EMA and MHRA etc. The data has been approved with zero queries. We supported our customers to successfully addressed the regulatory queries from various regulatory authorities.

Our Analytical Method Development strategy involves the use of proper scientific approaches, literature review, ICH guidelines and regulatory requirements which leads to the robust and stability indicative methods. Robust and stability-indicative methods are significant drivers to ensure product quality and faster regulatory approval.

A dedicated team can be assigned, for a particular project, based on customer requirements.
All the Equipment's was installed as per "21CFR part 11" compliance, server-based and enabled audit trials even to stand-alone systems.

1. FDA Registered - FEI Number - 3017524864.
2. D-U-N-S Registration Number - 86-134-3582.

:: Our Services Are::
1. Analytical Method Development & Validation for Nitrosamine Impurities by LC-MS/MS.
2. Analytical Method Development & Validation for Genotoxic Impurities by LC-MS/MS.
3. Analytical Method Development & Validation by HPLC (RID, PDA & UV).
4. Analytical Method Development & Validation by GC-HS.
5. Assay and Related substances Method Development and Validation.
6. Dissolution Method Development & Method Validation by HPLC.
7. Dissolution Method Development & Method Validation by UV.
8. Forced Degradation and Photo Stability Studies.
9. Stability Sample Analysis.
10. Cleaning or Residue Method Development and Validation by HPLC and UV.
11. Chiral Method Development and Validation.
12. Analytical Method Transfer.
13. Detoxification Method Development for potent drugs.
14. Excipients Analysis by HPLC and GC as per the Monograph.
15. Partial Method validations for Pharmacopeial Methods.
16. Comparison Studies with RLD.
17. DPDM Studies for Solid Orals.
18. Infusion Studies for Injectables.

Jansat Labs

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