Regulatory Affairs & Market Access Solutions for Greater China and Asia

Cisema is a specialized regulatory affairs and market access consultancy supporting pharmaceutical, biotechnology, medical device, diagnostics, and healthcare companies seeking to enter and expand across Greater China and Asia.

Our team provides end-to-end support throughout the product lifecycle, including:

• Regulatory strategy and pathway assessment

• Product registration and marketing authorization applications

• Medical device and IVD regulatory compliance

• Clinical trial regulatory support

• Labeling, artwork, and technical documentation review

• Regulatory intelligence and gap assessments

• Market access and commercialization planning

• Local agent and in-country representative services

• Lifecycle management, variations, and renewals

With deep expertise in China, Hong Kong, Taiwan, South Korea, Singapore, Malaysia, Thailand, the Philippines, Vietnam, and other Asian markets, we help companies navigate complex regulatory requirements, reduce approval timelines, and bring innovative healthcare products to patients faster.

We welcome partnerships with pharmaceutical, biotech, medical device, digital health, and investment organizations looking for regulatory guidance, market expansion support, or strategic entry into Asian healthcare markets.