国际注册

Japan PMDA Certification

Provide Japanese communication services for domestic enterprises to obtain PMDA (Pharmaceuticals and Medical Devices Agency) certification.

Services provided by Plutoheat:

• Submission of PMDA certification application documents.

• Communication between regulatory authorities and enterprises before and after on-site PMDA inspections.

• Full Japanese translation services (interpretation + written translation) during PMDA certification.

  
  

U.S. FDA Certification

Guide domestic active pharmaceutical ingredient (API) and intermediate manufacturers in establishing a GMP system compliant with U.S. FDA requirements, as well as DMF drafting, review, and guidance.

Services provided by Plutoheat:

• Guide domestic API and intermediate manufacturers in establishing a GMP system compliant with U.S. FDA requirements.

• Drafting of new Drug Master Files (DMFs).

• Review of existing DMFs.

• Guide factories in DMF preparation.

  
  

South Korea Registration

Provide services for domestic enterprises to submit registration documents and on-site certification to MFDS (Ministry of Food and Drug Safety).

Services provided by Plutoheat:

• Provide local agents and guide document preparation and submission.

• Communication between regulatory authorities and enterprises before and after on-site inspections.