Laviana Pharma has a certified ISO9001 Quality Management System following FDA cGMP, ICH Q series (and other) regulatory and industry guidelines and requirements. Laviana’s quality and compliance track record, ensure our clients peace of mind, knowing every project exceeds regulatory standards.

Laviana Pharma Quality Management System:

◎Laviana Pharma (Tianjin) Co., Ltd.    

As the R&D center of Laviana Group, we have passed ISO 9001 certification and established a R&D quality management system applicable to product development, preclinical and clinical Phase II of new drug development following Good Manufacture Practice (GMP), the Provisions for Drug Registration, the Good Clinical Practice (GCP), ICH Q7 and other rules and regulations to ensure compliance and efficient management of processes, records and data.

◎Laviana Pharma (Jiangsu) Co., Ltd.

As a pilot magnification site, we have established a quality management system in accordance with ISO 9001. Combined with the requirements of commercial RSM and regulatory trends of pharmaceutical intermediates, we have further enhanced our quality system with reference to the GMP, ICH Q7 and ICH Q10 rules and regulations to ensure the continuous stability and high quality of our products.

◎Laviana Pharma (Cangzhou) Co., Ltd.

As the production base of high-end pharmaceutical intermediates and commercial API products of Laviana Group, we have established a compliant quality management system applicable to the commercial base by referring to FDA, ICH, EMA and CFDA GMP to lay a foundation for the further development of the company.