Safety and Regulatory Compliance
Manufacturing facilities are equipped with all necessary safety features such as rupture disc/ safety valves for all reactors and process vessels, machine guarding, zero-speed interlock, nitrogen blanketing system, flameproof equipment, and level indicators for storage tanks. We also provide anti-static clothes, packing materials, and ‘touch me pads’ to dissipate static charges.
The plants are designed to ensure compliance with all safety and quality-related regulations. A dedicated production team supported by process engineers, process safety engineers, environment and human health, safety, and security (EHSS), quality assurance (QA), and quality control (QC) teams supervise all production activities. The production team uses an SAP-enabled system to track the progress of all production-related activities from receipt of raw materials to the shop floor, including sampling to QC and the subsequent product release.
The United States Food and Drug Administration (USFDA), Pharmaceuticals and Medical Devices Agency (PMDA), and other regulatory bodies with a ‘NO’ observations status facility will be considered.
Capabilities
Chemistry Capabilities
We track proven record of handling a wide range of complex chemical conversions at scale, using various reagents. These conversions include both modern chemistry technologies as well as conventional chemistry conversions such as asymmetric chiral inductions utilizing various asymmetric catalysis, organometallic reagents, etc. Metal catalyzed C-C bond.
Process and Analytical Validation
An expert in creating a straightforward strategy to perform process validation studies for intermediates, active pharmaceutical ingredients (APIs), and highly potent active pharmaceutical ingredients (HPAPIs) at the right stage of development. Design and control manufacturing processes to ensure that in-process materials and products consistently and reliably meet predetermined quality requirements.
The scope of activities includes process control verification (PCV) studies, failure mode and effects analysis (FMEA), analytical method validation, engineering, validation batches, and associated documentation, including all required protocols and reports. Provided regulatory guidance in setting specifications, method development, and validation, as well as in conducting stability studies.