International Registration

I. Japan PMDA Certification
Provide communication in Japanese to help domestic enterprises be approved by PMDA.
Services provided by Nanjing Pharmacare Co. Ltd:
1. Submit the application of PMDA Certification.
2. Communicate with official agency and enterprise before and after the on-site inspection.
3. Provide Japanese interpretation and translation throughout the PMDA Certification.
 
II. US FDA Certification
Give guidance to domestic API and intermediate enterprises to establish GMP in compliance with US FDA, and provide the preparation, review and advice of DMF.
Services provided by Nanjing Pharmacare Co. Ltd:
1. Guide domestic API and intermediate enterprises to establish GMP in compliance with US FDA.
2. Prepare the new DMF.
3. Review the DMF provided.
4. Guide factory to prepare the DMF.
 
III. Drug Registration in the Republic of Korea
Provide services to domestic enterprises for submitting dossier to MFDS and the on-site inspection.
Services provided by Nanjing Pharmacare Co. Ltd:
1. Provide local agents and guide the preparation and submission of dossier.
2. Communicate with official agency and enterprise before and after the on-site inspection.