We are in full compliance with GMP regulations and effectively manage various aspects such as record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
Registered with FDA
Our facility has officially notified the U.S. Food and Drug Administration (FDA) of its existence and its activities related to the production, processing, packing, or storage of food, drugs, medical devices, or other regulated products. This registration is a legal requirement, and it provides the FDA with essential information about the facility, which is used for regulatory and inspection purposes. It allows the FDA to monitor and inspect the facility to ensure compliance with regulations and to protect public health and safety.
ISO9001 Certified since 2019
We have established and maintains robust quality management system, including a strong customer focus, process improvement, documentation of processes and procedures, monitoring and measuring performance, and a commitment to continual improvement. Our commitment is to consistently provide services that meet customer requirements and comply with applicable regulations and standards.
Client GMP Audit
Our sites have been audited by many clients for whom we have manufactured API, RSM and GMP intermediates.
Our Quality Assurance (QA) team ensures pharmaceutical products are produced in compliance with strict quality and GMP regulatory standards. Strict adherence to GMP standards and regulations is essential to ensure the safety, efficacy, and quality of pharmaceutical products.