Industries We Serve with Our Market Access, Quality Compliance & Regulatory Affairs Consulting Services
Cisema provides trusted regulatory affairs consulting services to help companies succeed across the Asia Pacific region. With deep expertise in China and the Hong Kong SAR, and expanding support across Southeast Asia, South Korea and Taiwan, we work with clients in diverse regulatory environments. Backed by decades of experience in regulatory affairs consulting, our team of regulatory experts delivers comprehensive regulatory services, providing end-to-end support for compliance and approvals. We have a proven track record of achieving successful regulatory outcomes for medical devices, IVDs, pharmaceuticals, quasi-drugs, cosmetics, health products, consumer goods, and industrial products. Our expert guidance ensures smooth market entry, regulatory compliance, and long-term success in one of the world’s most dynamic regions.
Industries We Serve
We support companies in a wide range of regulated industries, with a focus on streamlining compliance and approvals for our clients. We help them meet the evolving regulatory landscape and compliance requirements, accelerate approvals, and maintain product quality throughout the lifecycle. For each industry, we develop a tailored regulatory strategy and identify the optimal regulatory pathway to ensure efficient progression through approval stages and reduce risks.
Medical Devices
We assist manufacturers with product registration, clinical trials, post-market surveillance, quality control, and the implementation of quality management systems. As well as inspection and sourcing services, in China, Hong Kong and Taiwan and across Southeast Asia.
In Vitro Diagnostics (IVDs)
Our team helps IVD companies navigate rigorous clinical validation, registration, and post-market requirements, ensuring compliance with the latest regulatory and clinical guidelines. We also deliver quality control, inspection, and sourcing services across China, Hong Kong, Taiwan and Southeast Asia.
Pharmaceuticals
From early development through to commercialization, we support drug manufacturers throughout the entire drug development process, providing strategic guidance, submission support, and GMP alignment for success across Asia Pacific.Our team has extensive expertise in the preparation and submission of drug applications, including ANDAs and NDAs, ensuring regulatory compliance and smooth interactions with agencies.
Biotech
We provide regulatory guidance for biotech innovators across Asia Pacific, supporting clinical trial design, biosafety clearance, import licensing, and alignment with regulators' expectations.
Quasi-Drug Products
We support foreign manufacturers throughout the entire Korean quasi-drug registration process, from initial feasibility assessment and classification through MFDS submission, Korean labeling, import coordination, and ongoing lifecycle compliance.
Cosmetics & Ingredients
We support cosmetic and ingredient manufacturers throughout the full product lifecycle in China and Taiwan from pre-registration or notification to post-market. We are your “Responsible Person” and ensure quality compliance with Chinese and Taiwanese regulations, assisting in preparation for NMPA and TFDA audits as required.
Health Foods & Supplements
We handle regulatory strategies, raw material approvals, testing, and registrations for dietary supplements and health foods. Our team ensures quality compliance and smooth market entry.
Veterinary Drugs & Pet Food
We support MARA interactions, registration, licensing, and testing for pet foods and veterinary medicinal products entering the Chinese market.
Industrial Goods & Consumer Products
We help you get your products on the market faster, from electronics and toys to machinery, telecom, and automotive parts. Our team manages CCC, HAF 604, CML, CEL, RoHS, NAL, SRRC, and more. From testing and documentation to renewals and authority approvals, we streamline every step to ensure full compliance with China’s regulations.
Why Work with Cisema?
One Partner, Full Lifecycle Support
From pre-market strategy to post-market compliance, we provide support to internal regulatory teams and ensure seamless lifecycle management.
Regional Reach, Global Presence
Based in Asia and Europe with a global team delivering global reach.
Cross-Industry Expertise
Pharma, biotech, medical devices, cosmetics, supplements, veterinary, industrial and consumer goods.
Proven Results
Over 20 years of regulatory submissions, regulatory expertise, and approvals to drive business success.
