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Asia Regulatory Strategy

CSOFT’s expert Asia regulatory strategy consultants provide our clients with insight into China’s pharmaceutical industry and help strategize regulatory and commercialization plans. We strive to ease complex issues our clients are facing such as obtaining the NMPA’s approval to register as well as to incorporate new medical products into China’s market.

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Before introducing new drugs into the Chinese market, companies must obtain approval from NMPA and create proper pricing and branding for the products. Our Asia regulatory strategy experts will work directly with your team to perform a comprehensive analysis and evaluate business opportunities versus risk factors.

The consultant team will give our clients specific guidelines on how to register their medical products and obtain faster approval from the NMPA. Afterward, we will design a plan to launch the product into China’s market and assist its implementation. Our team is dedicated to minimizing our clients’ risk while maximizing their business value and profits.

Medical Product Registration

The complexity of Asia Regulatory Strategy

Clinical Trials in Asia: Methodology


    Data analytics & evaluation skills

    Product gap analysis

    Access to first-hand
    market data & intelligence

    Access to first-hand
    market data & intelligence


    Market research reports

    Data summaries


    Comments & feedback

Clinical trials in Asia


Medical market

Healthcare system

Pharmaceutical regulations

Latest updates and revisions to regulations

Cultural and linguistic differences


RA executives

International marketing and sales team

Key opinion leaders (KOLs)

Local experts in NMPA regulations and clinical trials in China market