Rama G.S.A.K's Colleagues at Jansat Labs
Rama G.S.A.K's Contact Details
Jansat Labs
Rama G.S.A.K's Company Details
JanSat Labs is a US-FDA REGD. Testing Laboratory and Centre of Excellence Providing Services in Quality Control / Analytical Research Development Testing Services.We are supporting to address the Deficiency queries for Regulatory Authorities like US-FDA, EMA, MHRA, ANVISA, K-FDA and etc.We provide full support for regulatory queries received for the submitted DMF.We support the domestic and global pharmaceutical industry from the developmental stage to commercial products.Analytical Method validation is one of the most crucial components in any regulatory submission.Our analytical method validation protocols and analytical method validation reports are based on globally accepted guidelines such as ICH, FDA, ANVISA, K-FDA, MHRA, EMA requirements and cover various parameters.We are extensively capable of validating methods to support DMF/ANDA filings.We offer a flexible approach that enables customers to choose from a wide selection of services to develop a project plan which meets their specific needs.Our team also adapts communication and reporting channels through a project management system to match customer-specific requirements.Robust and stability-indicating methods are significant drivers to ensure product quality and ensure faster regulatory approval.Our method development strategy involves the use of proper scientific approaches and scientific literature reviews which lead to the appropriate selection of analytical techniques forthe targeted product.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 and enabled audit trials even to stand-alone systems.FDA Registered - FEI Number - 3017524864.D-U-N-S Registration Number - 86-134-3582.The Facility Situated at Aleap Industrial Estate, Pragathi Nagar, Kukatpally, Hyderabad, Telangana & INDIA.