Our Services Across Asia Pacific

Cisema delivers expert regulatory affairs, quality assurance and clinical development support for companies entering and operating in the Asia Pacific region. With 16 offices across 13 countries, we provide local insights, global coordination, and deep industry experience to help you meet compliance requirements and achieve faster market access.

Our Regulatory Affairs and Quality experts are fluent in a wide range of Asian and European languages, including Chinese, English, German, Japanese, Korean, Vietnamese, Thai, Bahasa Malay and Indonesian, French, Italian and Spanish, ensuring seamless communication across borders and time zones. Whether your headquarters is in North America, Europe, or Asia, we help bridge language and cultural gaps for smooth project execution.

Cisema Countries Covered
Drug products inside delivery device

Why Work with Cisema?

Local expertise with global reach

Our bilingual teams bridge international quality standards with local regulations

Proven track record

Over 20 years supporting market approvals and compliance in China and Asia Pacific

End-to-end solutions

From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle

Industry breadth

Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods

Role of a China Agent

Latest Insights

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CDE Releases 2025 Annual Report on the Progress of Clinical Trials for New Drug Registration in China

Explore the latest data on China’s clinical research landscape, including record trial activity, shorter development timelines, and emerging R&D trends.

July 24, 2026
CDE Releases 2025 Annual Report on the Progress of Clinical Trials for New Drug Registration in China

China Targets 65 Drugs in Its 12th National Procurement Round

The 12th national VBP round introduces tighter quality, manufacturing, and IP requirements that pharmaceutical companies must meet to compete.

July 24, 2026
China Targets 65 Drugs in Its 12th National Procurement Round

China CDE Defines Classification Rules for Cell & Gene Therapy Drugs

New NMPA CDE guidelines define CTMP and GTMP boundaries, affecting development strategy, CMC planning, and regulatory engagement in China.

July 24, 2026
China CDE Defines Classification Rules for Cell & Gene Therapy Drugs

China's 2026 Essential Medicines Adds More Innovative Drugs

China's updated National Essential Medicines List expands access to innovative medicines, creating new opportunities and strategic considerations for pharmaceutical companies.

July 24, 2026
China's 2026 Essential Medicines Adds More Innovative Drugs
A middle-aged man with glasses is looking down thoughtfully as he pours medication or pills from a small white bottle with a yellow label into his open palm.

China NMPA Expands Priority Review for Chemical API Marketing Authorization Applications

China's NMPA expands priority review eligibility for chemical API marketing authorization applications, supporting domestic API production and drug supply.

July 23, 2026
China NMPA Expands Priority Review for Chemical API Marketing Authorization Applications
Chemical API Manufacturing

China Releases 2026 Anti-Corruption Priorities for Pharmaceutical Sales & Medical Services

China's 2026 enforcement priorities expand scrutiny of pharmaceutical sales, procurement, pricing, data security, and compliance across the healthcare sector.

July 23, 2026
China Releases 2026 Anti-Corruption Priorities for Pharmaceutical Sales & Medical Services
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Contact Cisema for Support in Successfully Reaching Your Regulatory Goals in Asia Pacific

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