Medicinal Chemistry
Compound Screening
DMPK
Safety & Toxicology
Bioanalytical
CMC
Medical Writing
Clinical Monitoring
Regulatory Affairs
Data Management and Statistical Analysis
Clinical Development Strategy
Site Management (SMO)
Subject Recruitment
Medical Device / IVD
Multi-region Clinical Trial (MRCT)
Vaccine Clinical Trial
Clinical Development
Regulatory Affairs
As your full-service regulatory partner, we deliver sound strategies and solutions to address your regulatory challenges.
Drive Your Products on the Right Track
Whatever your stage of clinical development, you need a trusted partner providing global regulatory capabilities to support your product. Tigermed’s consultants understand the importance of delivering sound regulatory strategies and operational support for your products, and provide you with feasible approaches and act as liaison with various regulatory agencies, both on technical and regulatory issues.
By continuously monitoring the global regulatory landscape, and years of submission experiences with NMPA, FDA, EMA, we can advise you across all spectrum of activities and technical functions to stay ahead of any regulatory risks and keep your research on time and budget.
Global Regulatory Affairs
Expertise. Strategy. Delivery.
Full Regulatory and Submission Services
Global regulatory services for innovative drugs & generics in IND / CTA / NDA.
Extensive experience in regulations of NMPA, FDA, EMA, and international regulatory authorities.
Global and Local Regulatory Insights
A team of nearly 60 seasoned experts possessing profound insights into the regulatory reforms of the FDA, NMPA, and European healthcare authorities.
Feasible Regulatory Strategy
Providing feasible submission strategies and proactive planning, applying up-to-date, robust regulatory intelligence.
Demonstrated Track Record
We have successfully supported thousands of regulatory approvals globally, including MRCT approvals of COVID-19 vaccines in Africa, Europe and APAC.
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