Regulatory Affairs Consultant
Specialized regulatory services across pharmaceuticals, medical devices, quasi-drugs, cosmetics, health foods, veterinary products, industrial and consumer goods.
Cisema is your trusted regulatory affairs consultant for China, Hong Kong, Taiwan, South Korea and Southeast Asia. With significant regulatory experience, we deliver customized regulatory strategy, authority communication, and full lifecycle management tailored to your product type and regulatory challenge. Whether launching drug applications, registering a medical device, or filing a cosmetic or health supplement, our regulatory affairs experts provide hands on support from submission to surveillance, ensuring successful market entry in key markets.
Regulatory Intelligence
In today’s fast-paced regulatory landscape, we keep our clients ahead by delivering timely regulatory intelligence. We continuously monitor and analyze regulatory changes, updates, and trends from regulatory agencies and regulatory authorities not only in the jurisdictions we specialize in but also worldwide. With our deep understanding of both global regulatory requirements and local requirements, we provide actionable insights that help companies anticipate potential challenges, adapt strategies, and maintain compliance. By taking this proactive approach, we not only support the development of effective regulatory strategies but also maximize approval success and minimize costly delays, ensuring our clients maintain a competitive edge.
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Pharmaceutical & Biotech Regulatory Services
The Asia Pacific region offers major opportunities for life sciences companies, but success requires more than global documentation. At Cisema, we provide tailored regulatory affairs consulting that combines regulatory intelligence, local expertise, and operational precision. From clinical trial applications to post-market lifecycle management, our experienced team reduces approval risks, ensures compliance with local requirements, and streamlines regulatory submissions to accelerate successful market entry across the region.
Regulatory Strategy & Planning
Dossier Preparation & Submission Management
CMC & GMP Support
Labeling & Promotional Compliance
Local Representation
Medical Device & IVD Regulatory Services
As a medical device regulatory affairs consultant, we help manufacturers align with regulatory requirements, achieve product approvals, and stay compliant throughout the regulatory pathway.
Product Registration & Classification
Testing & Clinical Requirements
Combination Products
Quality Compliance & PMS
Local Legal Representation
Quasi-Drug Products
As a regulatory consultant and License Holder in South Korea, we assess your product category, identify the correct MFDS pathway, prepare the required documentation, and support communication with Korean authorities and relevant import bodies.
Regulatory Strategy & Classification
Dossier Preparation & Submission
Korea License Holder
Cosmetic Regulatory Services
As a cosmetic regulatory affairs consultant, we help companies ensure compliance with regulatory requirements in both China and Taiwan.
Product Filing & Registration
Responsible Person Representation
Labeling, Packaging, & Claims Review
Cosmetic Testing & GMP Compliance
Post-Market Surveillance & Cosmetovigilance
Health Food & Supplement Regulatory Services
We act as a health food regulatory affairs consultant, supporting product development and helping companies achieve market access while meeting regulatory requirements.
Regulatory Classification & Filing
Label & Ingredient Compliance
Safety & Functional Testing
Responsible Agent & Post-Market Compliance
Veterinary Medicines & Products
As a veterinary regulatory affairs consultant, we offer regulatory expertise for MARA and NMPA submissions to support marketing authorization of veterinary products.
Product Registration & Classification
Dossier and Safety Support
Labeling & Authority Engagement
Industrial & Consumer Goods Regulatory Services
We deliver regulatory consulting for industrial and consumer goods, providing a flexible approach that supports global regulatory certifications and ongoing compliance.
Product Certification & Testing
Labeling & Customs Compliance
Legal Representation & Ongoing Compliance
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.
