Regulatory, Market Access, & Quality Compliance Services

We deliver regulatory affairs, market access, quality compliance, clinical development, authorized representative, product safety certification, testing and sourcing solutions. 

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Regulatory strategy
Global regulatory strategy
Regulatory affairs experts
Regulatory affairs consulting
Evolving regulatory
Drug development
Scientists in white lab coats and safety goggles working with electronic circuit boards and taking notes.Enabling Compliance across Asia Pacific

Enabling Compliance Across Asia Pacific

Cisema is your trusted adviser for navigating the complexities of the Chinese and APAC markets. Our teams of experts provide comprehensive solutions, ensuring your products meet all the necessary requirements for success. With Cisema, you can confidently accelerate your market entry, comply with local regulations and successfully achieve your business goals.

Our services span regulatory consulting to quality compliance, from clinical development to China compulsory certification (CCC) and quality product sourcing.

How We Help Our Clients

Covering the entire product lifecycle, we provide a comprehensive range of services, from one-off project-based deliverables to specialist regulatory consulting or ongoing partnership solutions for larger initiatives.

With extensive experience across many industries, Cisema helps clients meet regulatory requirements across the Asia Pacific region while maintaining their product quality and achieving customer satisfaction. Our regulatory consultants guide clients through complex regulatory frameworks, identifying potential challenges and risks, avoiding non-compliance, and improving efficiency across regulatory processes.

We support drug applications, reporting obligations, and post-market requirements, ensuring alignment with local requirements and the expectations of regulatory agencies. Whether providing strategic advice or on-site support, our team helps you develop tailored solutions that meet customer expectations and ensure long-term reliability.

At Cisema, we understand that excellence in regulatory compliance makes a real difference. Our experts combine deep knowledge and proven practices to strengthen your compliance systems, streamline interactions with authorities, and ensure your product reaches the market faster and without delays.

From regulatory intelligence to ongoing compliance, we partner with customers to create efficient, future-proof solutions. Let us help you navigate China’s complex regulatory landscape — with clarity, confidence, and a commitment to results.

How We Help Our Clients

Explore Our Services 

Development & Strategy Consulting

Cisema experts will guide you at every stage of product development, ensuring compliance, strategic alignment and a successful market entry. We facilitate interactions with regulatory agencies to streamline the approval process.

Market Access

We guide you through the Life Sciences reimbursement landscape, ensuring full regulatory compliance while accelerating approvals. Our team crafts strategic pricing plans, conducts budget impact analyses, and supports NRDL (drug reimbursement) negotiations to optimize your success. 

We also assist with exporter regulatory requirements such as certification documentation, custom codes, pre-submission prerequisites and much more.

Regulatory Affairs

We recognize the complexities and challenges of handling regulatory affairs across China and the wider APAC region. From strategic planning to engaging with regulatory authorities, our consultants offer full-spectrum support across the regulatory journey. We act as your authorized representative across the region.

Medtech CRO: China Clinical Trials, Clinical Evaluation & Observational Studies

Cisema experts will guide you at every stage of product development, ensuring compliance, strategic alignment and a successful market entry. We facilitate interactions with regulatory agencies to streamline the approval process.

Vigilance & Post-Market Surveillance

Ensuring patient safety and meeting not only Chinese but also global regulatory requirements can be challenging.
With strong regulatory intelligence and deep expertise in local and regional safety standards, we support clients in developing reliable monitoring systems, ensuring continuous compliance, and achieving long-term quality and success throughout the product lifecycle.

Quality & Compliance (Control, Assurance, Inspection)

We provide reliable guidance to ensure your products are compliant market-ready. 

By strengthening quality systems and helping you prepare for and navigate regulatory on-site and remote audits, we ensure seamless quality control, assurance, and compliance across the region. 

Product Sourcing Agent

We are your trusted sourcing partner in China and across Asia Pacific, connecting you with a vast network of verified, pre-approved suppliers across diverse industries. 
Our sourcing experts manage supplier identification, negotiation, and quality control. Your team can focus on core operations while we streamline and optimize your supply chain.

Ready to Navigate Complexity & Achieve Success in China and Across Asia Pacific?

Let Cisema help turn your plans into reality.

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Who We Help

To provide the best services to our clients, we divide our expertise and innovative solutions across 8 business sectors. Learn more about how we can help you navigate the region's complexity according to your specific needs.

Medical Devices

We help businesses navigate the evolving Medical Device ecosystem with our extensive expertise. From Clinical Trials to Product Registration and Post-Market Surveillance - learn how we can support your success.

In-vitro Diagnostics

With typically stricter clinical validation requirements, our team helps to ensure your IVDs pass all the evaluations necessary to enter the markets and remain compliant.

Pharmaceuticals

We support the entire product lifecycle, from target identification through implementation, product extension, and redevelopment, by enabling efficient innovation launch, regulatory submission, and commercialization.

Biotech

We provide regulatory support for biopharma submissions, covering classification, clinical trial alignment, GMP compliance, import licensing, and engagement with regulatory authorities. Our expertise helps you understand evolving guidelines, traceability requirements, and HGR regulations to accelerate approval and market access.

Cosmetics

We support cosmetic and ingredient manufacturers throughout the full product lifecycle, from pre-registration to post-market. Acting as your “responsible person,” our qualified Cosmetics Quality & Safety Managers handle filings, registrations, ingredient code applications, and testing. We ensure quality compliance and assist in preparation for regulator's audits.

Health Foods & Supplements

From sound regulatory strategies to preparing registrations and filings to supporting new raw material approvals, we help bring your products to market smoothly. Our team oversees quality compliance, inspection readiness, and testing of supplements, health foods, and raw materials in accredited local labs, ensuring your products meet all regulatory requirements.

Veterinary Drugs & Pet Food

We support veterinary drug and pet food manufacturers with registration, import licensing, and compliance. As your local representative, we handle regulatory authority interactions, oversee applications for new ingredients, ensure GMP standards, and manage product testing in certified labs, guiding you from market entry to post-launch.

Industrial Goods & 
Consumer Products

We support companies across many industries with regulatory consulting for products such as electronics, machinery, automotive parts, telecom devices and toys. As your local representative, we handle China certifications, manage authority interactions, coordinate testing and inspections, and support documentation, renewals, and ongoing compliance, guiding you from market entry to post-launch.

Learn More About Cisema

Regulatory Affairs Consultants, Cisema, are here to help you access China and Hong Kong

Founded over 20 years ago, we’re proud to remain a family-owned business. Thanks to our personal approach and deep expertise, we’ve helped companies of all sizes, from ambitious startups to industry leaders, to enter and comply with the Chinese and APAC markets successfully. Discover more about us and how you can how you can benefit from our unique expertise.

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How We’ve Helped Clients with Our Expert Guidance

Read about how we work with clients to find solutions, bringing together deep industry knowledge with leading talent.

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April 18, 2026

China Manufacture License Renewal for Level A2 Pressure Vessels

Cisema supported Inox Torres Group in successfully renewing its China SELO license for Level A2 pressure vessels through expert audit preparation and regulatory guidance.

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China Manufacture License Renewal for Level A2 Pressure Vessels
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Latest Insights

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China NMPA Issues 26 Medical Device Standards Affecting Orthopedics, IVDs, & Software

The 26 new medical device standards cover orthopedic implants, IVDs, active devices, and software risk management.

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China’s NMPA Seeks Public Feedback on First Mandatory Toothpaste Safety Standard

China’s NMPA has opened consultation on a draft mandatory toothpaste safety standard that could tighten product requirements.

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Contact Our Consultants & Discover How We Can Support You

Let Cisema help turn your plans into reality.

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