Quality Assurance Management System
In its continuing legacy to provide uncompromised quality, Embio’s operational resources are in sync with the global regulatory requirements. The company has built up a complete QMS, encompassing regulatory affairs, QA, QC, DCS enabled production and complete documentation.
"Quality Systems forms the backbone of the way we do our business"
We have comprehensive approach to an effective pharmaceutical quality system that is based on National and International regulations. A highly qualified and experienced team ensures that Good Manufacturing Practices are adhered to at all stages of processing.
The Quality Assurance team ensures that National and International regulations are implemented across all our operations to ensure qualitative output at each step. We have requisite infrastructure & expertise to assure effective Quality Management System at each node.
A well-equipped and state of the art laboratory ensures stringent quality of all intermediates and finished products. With support of micro lab in organization. The laboratory is equipped with all advanced instruments such HPLC, HSGC, FTIR, UV, Polarimeter, Malvern Particle Size Analyzer etc.
The regulatory affairs section is managed by a competent team with varied experience in filing CTD DMF, US DMFs, KDMF, COS and other registrations required by various International regulatory authorities and individual country specific requirements.