Our Quality assurance team assesses client’s requirements and ensures that these requirements are met. QA systems at Maithili Life Sciences are ICH and ISO compliant.

The QA systems are independent from production.

The many responsibilities of the QA team include, but are not limited to:

The Quality assurance team ensures that API’s and advanced intermediates produced during the various stages of manufacture comply with the cGMP Requirements. Further, the QA team is responsible for site specific, maintenance, compliance, realization and advanced development of internal Quality Management Systems (QMS). They plan, direct or coordinate quality assurance programs and formulate quality control policies.

Our Regulatory Affairs team works with project teams and interacts with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and anticipates what the regulatory authority will require before approving the product.

Our Regulatory Affairs personnel are responsible for tasks involving evaluating dossiers/queries and compilation of critical dossiers and queries, as and when required. They are also responsible for registration of products in various countries abroad as per the registration guidelines as well as filing of DMF’s in regulated markets.