QA-New Synthetics China (NSC)

Quality Management and Assurance

GMP culture across all staff & 20+ years of international cGMP experience.
Comprehensive Quality Management System
Professional Team
High-quality Facilities

QMS

1,Professional Microbiology Laboratory
2,QC Audit trail：
Agilent OpenLab Netversion & Thermofisher Chromeleon
3,Inspected by USFDA, CFDA, and PMDA
4,Strengthen QMS cGMP facilities based on ICH
5,Professional and standardized QC/ARD Lab

Professional Microbiology Laboratory

QC Audit trail：
Agilent OpenLab Netversion & Thermofisher Chromeleon

Inspected by USFDA, CFDA, and PMDA

Strengthen QMS cGMP facilities based on ICH

Professional and standardized QC/ARD Lab

QMS: Mature Expertise

Official Audits Over the Years

2021-

1、Site Change for APIs & Intermediates
2、Developing APIs & Pharmaceutical Excipients, filing DMF

2021-

2017-2020

2017
1、Filed 2^nd DMF
2、4^th US FDA inspection approval
3、PMDA renewal
2018 PMDA on-site inspection approval
2019 CFDA inspection approval

2017-2020

2012-2016

2012 1^st PMDA approval
2013 3^rd US FDA inspection approval
2014 3 APIs passed CFDA audit
2015 Filed ^1st DMF

2012-2016

2007-2011

2007 Step into API manufacture
2009 1^st US FDA inspection approval
2011 2^nd US FDA inspection approval

2007-2011

2014

3 APIs passed CFDA audit

2014

2013

3rd US FDA inspection

2013

2012

First PMDA approval

2012

2011

2nd US FDA inspection

2011

2009

1st US FDA inspection

2009

2007

Step into API manufacture

2007