From July 31 to August 1,the Nanjing facility of Milestone Pharma underwent an on site cGMP (Current Good Manufacturing Practice) inspection by the U.S. Food and Drug Administration (FDA). The company has now received the official notification and the Establishment Inspection Report (EIR), confirming that the quality management system at Milestone Pharma’s Nanjing laboratory is in full compliance with FDA cGMP requirements.
As an international provider of drug quality research services, Milestone Pharma is guided by the philosophy “Science drives quality; technology sets the standard.” The company is committed to building an integrated drug quality research technology platform that complies with global pharmaceutical regulations (including FDA, EMA, NMPA, and others), helping clients worldwide elevate the quality standards of pharmaceutical and healthcare products. This successful FDA on site inspection strongly demonstrates the company’s active commitment to a “high standard compliance” development philosophy, confirming that Milestone Pharma has achieved internationally advanced levels in its cGMP quality management system, project data consistency, and data reliability assurance.
Moreover, this achievement will accelerate the regulatory review and market approval of our clients’ products destined for global markets, further support our partners in their international expansion, and ultimately help deliver high quality, affordable medicines to patients worldwide.
Headquartered in Nanjing, the company operates nearly 10,000 square meters of CNAS accredited laboratories in Nanjing Jiangbei New Area and Shanghai Pudong New Area. An information management system covering the entire R&D process (including DMS, ELN, CDS, etc.) has been implemented, ensuring complete and reliable data, traceable processes, and compliant, efficient operations. The laboratories have successfully passed FDA on site inspections, EU Qualified Person (QP) audits, and multiple NMPA inspections, demonstrating internationally recognized quality management systems and exceptional compliance capabilities. With its comprehensive technology platforms, information management systems, and highly efficient and compliant operations as core competencies, Milestone Pharma continues to lead industry standards and accelerate drug development and commercialization.
To date, Milestone Pharma has provided high quality research and registration services to more than 2,500 pharmaceutical and biotechnology companies worldwide, delivering over 10,000 projects. Guided by a “customer centric” service philosophy, the company offers modular technology platforms and customized solutions to support the entire lifecycle of quality research – from early development and regulatory filing to product launch and post approval changes – helping clients overcome technical barriers, shorten R&D timelines, and achieve global market strategic positioning.
Milestone Pharma’s six core business systems cover:
Small molecule chemistry (innovative drugs, generics, APIs, and pharmaceutical excipients);
TIDES (peptide drugs, oligonucleotides, and related chemical conjugates);
Biologics (proteins, antibodies, bioconjugates, and vaccines);
Nanomedicines and advanced drug delivery systems;
Advanced therapy medicinal products (ATMP);
Drug-device combinations and packaging systems.
Copyright Notice: This article is from the Marketing Department of Milestone Pharma. Personal sharing on social platforms is welcome. Republication by media or organizations without authorization is prohibited. For republishing authorization, please contact: Marketing@mstonepharma.com
