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.

2,400+
Drug registration projects
700+
Global drug registration customers

Global Regulatory Affairs

  • IND & NDA Submission
  • CDE Communication Meeting Application
  • Submission Dossier Preparing
  • Gap Analysis
  • DMF/CEP Registration
  • Consulting Services
  • QC Testing Arrangement
  • Renew & Variation Application
  • Regulatory Strategy Development

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.

How We Ensure a Successful Submission for You

  • Our highly skilled team of global regulatory experts are devoted to providing support for your drug, biological product at any stage of clinical development.
  • Internal supervision and control from PD with abundant project experience to ensure project quality.
  • Experiences from ongoing projects enable us to receive the first-hand intelligence and up-to-date regulatory trends from the drug authorities.
  • In-depth expertise on regulatory filing of both domestic & imported innovative drug.

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