-
GMP Consulting
Every client is special, every factory and every company is different. We are experienced in the preparation of German and Chinese companies for inspections by the different European Authorities. Based on experience, the preparation of a company for the inspection starts with a severe assessment of the DMF or the final dosage form.
-
Product Registration
Together with our partner companies, we do DMF applications with the European Authorities. We have also successfully registered marketing authorisations in Germany and Austria; We are waiting for a registration in Spain and planning the next registration in Romania. We have also Chinese partner companies, which can register European products with the Chinese SFDA and also distribute them throughout China.
-
Audit
We provide third party audits for our European customers in India, China, Taiwan, Korea, Japan and other countries of the Far East. Our experienced, qualified teams with an audit experience of more than 350 audits perform final dosage forms audits, API audits, packaging material audits, excipient audits, as well as special audits like fermenative APIs, antibiotic APIs, anti-cancer product APIs and hormonal APIs. All auditors have to pass yearly seminars, including an examinations by European experts.
-
Market entry in China
With more than 10 year experience in doing business with Chinese and European companies, we can help you to plan your projects in China. We can address requirements and problems across borders of language, culture and legal framework.
-
Other Service
We supply you with expert advise for all GMP-relevant questions and give seminars in German, English and Chinese. We have seminars and slide shows in regard to all aspects of GMP in all three different languages.