Our China Regulatory Services Include:

• NMPA Regulatory Affairs Consulting: Expert guidance through China's National Medical Products Administration (NMPA) requirements.
• Regulatory Strategy Development: Crafting effective strategies for product registration and approval.
• Marketing Authorization Applications: Assisting with new product marketing authorizations.
• Gap Analysis & Remediation: Identifying and addressing compliance gaps in your documentation and processes.
• CMC Advisory: Comprehensive support for Chemistry, Manufacturing, and Controls.
• API & DMF Services: Assistance with Drug Master Files.
• Post-Approval Life Cycle Management: Ensuring ongoing compliance and product longevity.
• eCTD Publishing & Submission Services: Streamlined electronic dossier preparation and submission.
• ANDA and MA Holding Services: Support for Abbreviated New Drug Applications and Marketing Authorizations.
• Regulatory Due Diligence: Thorough assessments to mitigate risks.

Why Choose DDRegPharma?

With deep expertise in China's evolving regulatory environment, our dedicated team provides high-quality, timely, and cost-effective solutions. We help you navigate complex requirements, overcome challenges, and achieve your business objectives.