The manufacturing site conceptualization and designing include the designing of the facility that meets the local and international cGMP requirements as expected by various regulators worldwide. The requirements include and not limited to the layout designing of manufacturing unit, achieving the regulatory expectations of the clean room, Adequate and compliant validation of the Equipment, instruments and utilities and related documentation.
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The Efforts of Operon Strategist in helping us resolve our various regulatory queries have been outstanding. Their expertise & regulatory knowledge puts them on par with other globally recognized regulatory consultants.
We hired Operon consultant as a subject matter expert for overseeing sterilization activity by adhering to the protocol and for reviewing results and reports in line with global standards and our requirements for the commercial launch of a product in the global market. The team exceeded our expectations by providing quality outcome and played a vital role to launch the product in time.