中国药品注册

1. Import APIs Filing
We provide comprehensive consultation services for imported API filing and registration in China. Our services include individual dossier submission and collaborative support for bundled drug product reviews, ensuring successful technical evaluation of APIs and assisting clients in obtaining approval for related drug products.

Plutoheat (Hangzhou) Pharmaceutical Technology Co., Ltd. offers:
1.1 Guidance on preparation requirements for registration dossiers.
1.2 Review, analysis, and evaluation of submitted documents, with recommendations for improvement and supplementation.
1.3 Professional translation, compilation, and submission of registration materials.
1.4 Coordination of registration inspections, including application support, sample logistics, and progress tracking.
1.5 Continuous follow-up during API filing, including feedback on queries, liaison with CDE, and timely dossier amendments.
1.6 Provision of API technical documents and support during bundled reviews of drug products.
1.7 Post-approval services, including dossier updates and annual report preparation after registration number acquisition.

2. Import Drug Products Registration
We offer end-to-end regulatory consultation for the NMPA registration of imported drug products, helping clients secure marketing authorization in China.

Plutoheat (Hangzhou) Pharmaceutical Technology Co., Ltd. provides:
2.1 Clear guidance on dossier preparation and regulatory requirements.
2.2 Thorough review, assessment, and strategic advice on submitted documentation.
2.3 Accurate translation, systematic compilation, and timely submission of registration files.
2.4 Full support in inspection coordination—from application and sample delivery to tracking and follow-up.
2.5 Proactive registration monitoring, including query response, communication with CDE, and efficient dossier revisions.