1. Import APIs Filing
Provide consultation services for import APIs filing, including the submission of dossier for individual review and the cooperation in bundling review of drug products, to help pass the technical review of APIs, and assist customer enterprise in obtaining the approval of relevant drug products.
Services provided by Nanjing Pharmacare Co. Ltd:
1.1 Provide the preparation requirements of registration dossier.
1.2 Review, analyze and evaluate the documents provided, and offer advice on expansions and revisions.
1.3 Translate, compile and submit the documents provided.
1.4 Responsible for the application, sample delivery and tracking of registration inspection.
1.5 Follow up the APIs filing continuously. Feedback questions, contact with CDE and amend dossier timely.
1.6 Provide technical documents of APIs and answer related questions during the bundling review of drug products.
1.7 Update dossier for APIs filing and produce the annual report after obtaining the registration number.
 
2. Import Drug Products Registration
Provide consultation services to customers for import drug products NMPA registration to obtain the approval of drug products.
Services provided by Nanjing Pharmacare Co. Ltd:
2.1 Provide the preparation requirements of registration dossier.
2.2 Review, analyze and evaluate the documents provided, and offer advice on expansions and revisions.
2.3 Translate, compile and submit the documents provided.
2.4 Responsible for the application, sample delivery and tracking of registration inspection.
2.5 Follow up the drug products registration continuously. Feedback questions, contact with CDE and amend dossier timely.