Clinical Development Services
Cisema delivers clinical development services to support companies across pharma, biotech, medical devices, in vitro diagnostics (IVDs), health food, food for special medical purposes (FSMPs), supplements, and veterinary drugs. With more than 20 years of experience in China and the Asia Pacific region, we help life sciences companies bring innovative products to market efficiently and in full compliance with local regulations.
Our bilingual teams in Asia align clinical planning with regional regulatory frameworks to reduce risk, accelerate timelines, and support successful commercialization. From clinical strategy and trial design to regulatory submissions and post-market surveillance, we provide integrated support across the entire product lifecycle.
Clinical Development Services
Drug Development Strategy & Planning
We design tailored clinical development strategies aligned with product type, classification, and regional requirements. Our roadmaps integrate regulatory timelines, resource planning, and clinical milestones to support both early-stage feasibility and late-stage execution.
Our solutions include:
Regulatory & Clinical GAP Analysis
Our expert team conducts in-depth assessments of clinical data and technical documentation to evaluate alignment with the target market's regulatory standards. This process identifies evidence gaps, eliminates redundancies, and enhances the likelihood of successful submissions.
Our solutions include:
Expedited Approval Pathways
We guide clients through available expedited regulatory channels across China and APAC to accelerate time to market. Early engagement is critical; we assess eligibility and prepare all supporting documentation to maximize success under priority review mechanisms.
Our solutions include:
China Clinical Trials for Medical Devices & IVDs
Cisema is your go-to partner for seamless China clinical trials of medical devices and IVDs. We combine CRO-level operational precision with regulatory expertise to guide you from first concept to final NMPA approval. With deep local insight and a fully integrated approach, we help you cut timelines, boost data accuracy, and stay fully compliant every step of the way.
Our solutions include:
Regulatory, Scientific & Medical Writing
We develop clear, compliant, and regulator-ready documentation to support clinical and regulatory submissions across the region. Our writing services are tailored to local expectations, technical formats, and evolving standards.
Our solutions include:
Market Access & Commercial Strategy
Following product approval, we support your transition to commercialization by guiding pricing, reimbursement, and stakeholder engagement strategies. Our market access experts help you define and communicate your product’s value within the local healthcare landscape.
Our solutions include:
Post-Market Clinical Support & Real World Evidence
We support the full post-approval phase, helping you maintain regulatory compliance and generate robust evidence to demonstrate product performance, safety, and potential for label expansion.
Our solutions include:
Therapeutic Area & Product-Specific Expertise
Biotech & Advanced Therapies
We support strategic clinical planning and regulatory alignment, among others, for antibody-drug conjugate (ADC), gene therapies, cell-based products, and biologics. Our expertise spans early-phase feasibility through market authorization, ensuring compliance with APAC regulatory frameworks.
Pharmaceuticals
We guide pharmaceutical companies through every stage of the product lifecycle, from early development to market access. We deliver targeted regulatory strategy, CTA and IND preparation, gap analysis, and submission-ready documentation. Our team supports local study design, leverages expedited approval pathways, and drives market success through pricing insights, stakeholder engagement, and competitive intelligence.
Veterinary Drugs
We provide guidance for the clinical development of veterinary pharmaceuticals and health products, including study design, documentation, and regulatory submission for animal health authorities.
Medical Devices
We prepare Clinical Evaluation Reports (CERs), develop localized clinical trial strategies, and manage post-market surveillance for Class II and III devices, including high-risk implants and digital health technologies.
In Vitro Diagnostics (IVDs)
We deliver performance evaluation strategies aligned with regulatory expectations for IVDs and companion diagnostics, including clinical validation, analytical studies, and post-market performance evaluations.
Health Food, Food for Special Medical Purposes (FSMP), & Supplements
Our services include human clinical study design to substantiate functional claims and nutritional value, aligned with Chinese and regional health food 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.
