Regulatory
Regulatory Service
We integrate trading services, market development, licensing cooperation and regulatory support to help pharmaceutical manufacturers and buyers build efficient international cooperation.
Regulatory Service
QUIMFARMA provides full range regulatory and compliance support by working closely with partner manufacturers and coordinating professional consultation for DMF registration and EU-GMP compliance.
Services may include DMF compilation, submission and deficiency response, gap analysis, pre-inspection support, improvement strategies and lifecycle communication such as annual reports and post-approval changes.
We also establish a reliable communication bridge between manufacturers, customers and competent authorities, coordinating technical discussions and up-to-date regulatory requirements across international markets including the United States, Europe, Asia, Africa and Latin America.
- DMF compilation and submission coordination
- EU-GMP compliance consultation
- Gap analysis and pre-inspection support
- Deficiency response coordination
- Annual report and post-approval change communication
- Communication bridge among manufacturer, customer and authorities
Send Us Your Inquiry
Please share your product requirements, target market and required documents. Our team will review your request and get back to you as soon as possible.