On December 14, 2023, the Shanghai facility of Milestone Pharma received the official notification and Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA), confirming that its quality management system is in full compliance with FDA cGMP requirements. The inspection was successfully passed with zero observations (no Form 483 issued) – an outstanding achievement.
Around August 2023, both the Nanjing and Shanghai facilities of Milestone Pharma underwent separate FDA cGMP on‑site inspections. The Nanjing facility successfully passed in October. This “zero‑observation” result for the Shanghai facility further validates Milestone Pharma’s internationally leading performance in its cGMP quality management system, project data consistency, and data reliability assurance.
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). This “zero‑observation” FDA inspection result affirms the company’s long‑term dedication and investment. The entire organization consistently upholds high standards and rigorous requirements to ensure service quality and safety. This achievement not only validates the company’s quality management system but also recognizes the professionalism and execution capabilities of its employees.
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.
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. Looking ahead, Milestone Pharma will continue to uphold its “Serve You Better” service principle, delivering quality that exceeds client expectations, accelerating the regulatory approval of clients’ products destined for the U.S. market, and further supporting partners in their global expansion – ultimately helping provide high‑quality, affordable medicines to patients worldwide.
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); and 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
