QA&RA Department

1. We are characteristic of our job: we not only are responsible for quality assurance and regulatory affairs for our trading products, but also offer our domestic API manufacturers and customers overseas with such highly-qualified, standard, professional and quick services as COS dossier preparation and registration application, GMP audit, etc.
We own a professional team with master’s degree or above. They have a good command of English. They know well about pharmaceutical regulations in China, Europe and USA, production practices and requirements in quality management among our domestic pharmaceutical industries, as well as ICH Q7a and other GMP provisions. Reliability of our consulting services is effectively consolidated by our advantages such as top-class analytic instrumentations in our HFM Analysis Center jointly founded with Sichuan University, especially our competences on impurity profile study and our steady cooperation with experts in EU and USA pharmaceutical industries.
By virtue of our efforts, ten COS certificates have been granted to our customers and several DMF dossiers have been done. By virtue of our efforts, quality management systems of dozens of domestic API manufacturers have been improved in our GMP audit programs.

Training service	Training service

3. Our service scope
COS (or CEP) registration and revision application
Dossier preparation for COS or DMF
GMP consulting and audit
Establishing analytic procedures for refined chemicals and new products
Impurity profile study for COS/DMF
Preparation and identification of reference substances
4. Contact
   Dept Manager:Ms.Zeqiong LI
   Tel:86-28-86181366-111
   Fax:86-28-85449790/9188
   Email:zeqiong.li@huafemei.com