Regulatory, Market Access, & Quality Compliance Services Across Asia-Pacific

We understand the complexities of managing regulatory affairs across China and the wider APAC region, including CMC requirements for biopharma companies.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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

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.

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.

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.

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.

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.

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.