Our Capabilities: Clinical Development, Market Access & Regulatory Consultants
As your trusted regulatory partner, Cisema provides strategic and operational expertise to accelerate the successful commercialization of life sciences products and other regulated goods across China and the broader Asia Pacific region.
With over 20 years of in-market experience, we support clients throughout the product lifecycle, from clinical development and regulatory strategy to market authorization, quality system compliance, post-market surveillance, sourcing, and pre-shipment inspection.
With over 20 years of in-market experience, we support clients throughout the product lifecycle, from clinical development and regulatory strategy to market authorization, quality system compliance, post-market surveillance, sourcing, and pre-shipment inspection.
We facilitate effective engagement with competent authorities and ensure seamless navigation of local regulatory challenges. This empowers our clients to achieve timely market entry, sustain compliance, and address regulatory complexity in dynamic environments.
Clinical Development Services
Commercialization & Certification Strategy for Life Sciences & Regulated Goods
We combine regulatory intelligence with commercial acumen to help companies secure market access across Asia Pacific. Our consultants develop tailored strategies that align with local pricing, reimbursement, and procurement frameworks, while supporting global commercialization objectives.
Key solutions include:
We deploy technology-enabled platforms, centralized monitoring, and risk-based methodologies to improve regulatory compliance, streamline clinical operations, and ensure data integrity throughout the product lifecycle.
Market Access Consulting
Integrated Clinical & Regulatory Services for Life Sciences
Cisema provides clinical development services tailored to the regulatory landscapes of China and the broader Asia Pacific region. Leveraging over two decades of regional expertise, we support companies across the life sciences spectrum. Including pharma, biotech, medical devices, IVDs, health food, food for special medical purposes (FSMPs), supplements, and veterinary products through every phase of development and commercialization.
Our core solutions include:
- China Compulsory Certification (CCC)
- China Energy Label (CEL)
- State Radio Regulation of China Certifications (SRRC)
- China Manufacturing License (CML) from the Special Equipment Licensing Office (SELO) amongst others
We help you navigate local regulatory and commercial requirements while maintaining alignment with global standards and strategic goals.
Regulatory Affairs Consulting
Submission Strategy & Product Registration Across Sectors
Our team of regulatory affairs consultants provide strategic guidance and hands-on support to navigate product classification, registration, and lifecycle compliance. We advise across life sciences, health food, cosmetics, veterinary products, and regulated industrial and consumer goods.
Key solutions include:
- (Pre-) Investigational New Drug applications (INDs)
- Clinical Trial Applications (CTAs)
- (Pre-) New Drug Applications (NDAs)
- Marketing Authorization Applications (MAAs)
- Biologics License Applications (BLAs)
- Drug Master Files (DMFs)
Our deep understanding of and frequent communication with regulatory authorities enables us to anticipate challenges, support inspection readiness, and ensure long-term compliance across diverse regulatory environments.
Quality Management & Compliance
GxP Systems & Regulatory Compliance for Market Readiness
We support the design, implementation, and maintenance of quality management systems that meet both international standards and country-specific regulatory requirements. Our compliance consultants are industry experts in their respective domains: life sciences, food, cosmetics, and industrial sectors.
Key solutions include:
We align global quality frameworks with local implementation standards to ensure regulatory compliance and operational excellence. We provide guidance and support to clients on how to design quality systems that enhance efficiencies, reduce costs, and improve business effectiveness. By integrating technology, data-driven oversight, and scientific methodologies, we ensure seamless implementation and continuous improvement in compliance and quality management.
Pharmacovigilance & Post-Market Surveillance
Safety Monitoring & Lifecycle Compliance
We establish and manage post-market systems to meet pharmacovigilance and surveillance obligations across product categories and jurisdictions.
Key solutions include:
Sourcing Agent Services
Regulatory-Compliant Sourcing across Asia Pacific
We act as your strategic sourcing partner across China and Southeast Asia to ensure products meet all regulatory compliance and quality requirements prior to market entry.
Key solutions include:
Our local presence and deep expertise in APAC supply markets ensure sourcing strategies align with both regulatory obligations and business objectives.
Quality Control Pre-Shipment Inspection Services
End-of-Line Regulatory Checks for Export-Ready Products
We conduct detailed inspections to ensure your shipments meet compliance, safety, and contractual specifications before export.
Inspection types include:
Our experts help safeguard regulatory compliance and protect market access through rigorous end-of-line quality assurance.
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.
