Three integrated services supporting the journey from R&D to market
From clinical trials to market strategy, we bridge regulation and science
FUGA’s professional services
support every innovation on its journey to market
From clinical research and regulatory guidance to post-market surveillance,
we provide integrated, one-stop solutions!
CRO Contract Research Services
Preclinical trials, study design, and regulatory support
SMO Site Management Services
Site activation, participant recruitment, and on-site monitoring
CSO Commercial Support
Product positioning, strategic planning, and pharmaceutical marketing support
Detailed Services
01. Consultation and project advisory
02. Preclinical trial services
03. Laboratory and animal study, and GMP facility consultation
04. Clinical trial design and management | clinical assessment
05. Medical device risk assessment and validation
06. Quality systems, QA & QC
07. Regenerative medicine (combination products: tissue engineering)
08. National health insurance reimbursement consultation
09. GTP laboratories, cell therapy, and gene therapy
10. Medical regulatory consultation | health foods
11. Business operations assessment | medical aesthetic products
Comprehensive Development Support and Consulting
Precise recommendations and risk analysis at every step from laboratory to market
1. Risk Assessment and Technical Diagnosis
- Regulatory risk assessment
- Technical risk assessment
- Market risk and competitiveness assessment
- Business operations diagnosis and advisory
2. Preclinical and Laboratory Advisory
- Preclinical study design
- GTP / IVD laboratory design, testing, and validation
- Animal study planning and applications
- Quality system development (QA / QC)
3. Regulatory Consultation and Licensing Support
- Medical regulatory consultation (TFDA / FDA / CE / PMDA)
- Patent and intellectual property consultation
- Consultation on health foods, aesthetic products, and pharmaceutical advertising
4. Product Launch and Post-Market Monitoring
- NDA / IDE / PMA documentation and applications
- Medical device risk management and conformity validation
- Post-market surveillance
- Adverse event reporting and process audits (AE / SAE / ADR)
Clinical Trial Design × Applications × Monitoring × Data
Following international GCP standards, we provide end-to-end trial design, site coordination, monitoring, and reporting,
helping pharmaceuticals and medical devices advance smoothly to human trials
Trial Planning and Design
Study parameter setting and protocol writing
Applications and Submissions
Trial documentation, pharmaceutical NDA,
medical device IDE/PMA
Trial Execution and Monitoring
GCP, ADR, process audits,
and participant management
Data and Reporting
Results analysis, documentation,
and regulatory responses
Solutions from Class I medical devices to regenerative medicine
Support for early-stage device risk assessment, documentation planning, and regulations for high-risk Class III devices
Registration guidance for Class I, II, and III medical devices
Development guidance for tissue engineering and combination products
Cell and gene therapy trial planning and GTP laboratory setup
Regulatory strategies for vaccines, biologics, and other specialized products
Added Value to Take You Further
Beyond product development and registration, we provide training and regulatory support
Patent and intellectual property acquisition guidance
Pharmaceutical education and training course design
(Regulations / Quality / Application Practice)
Post-market safety surveillance (PMS) follow-up
Quality control support for health foods and cosmetics
Advertising regulatory compliance review
Fuga Company was established in 2002 as a Contract Research Organization (CRO) company