Regulatory Affairs

Regulatory Affairs & Registration

CR Medicon's Regulatory & Registration Team is led by our industry experts, each with more than 18 years of experience. We have a wealth of IND and NDA registration experience in chemical drugs and biological reagents, and have successfully completed numerous drug and medical device registration projects for domestic and foreign pharmaceutical companies. Leveraging the deep experience and extensive opinions from our KOL resources, we minimize your regulatory risks, shorten the registration time, and speed up your drug approval progress.

Services

Regulatory Consulting

Custom strategy planning and implementation guidance

Case-by-case problem analysis through product development and registration cycle

Project phase-level problem solutions

Registration path exploration for unknown areas

Registration Agent

Worldwide agent for innovative, modified, imported and generic drugs, medical devices

End-to-end management process follow-through

Clinical Trial Application (MRCT/IND/CTA),
Commercialization Application (NDA/ANDA/BLA)
and Supplemental Application

eCTD Submission System

eCTD dossier submitter

eCTD dossier self-checker

PDF editor

Advantages

  • Ability to establish registration paths in innovative areas
  • A core team with more than 10 years of industry experience each, well versed in both drug and device registration
  • Precise grasp and prediction of regulatory affairs
  • Long-lasting and unobstructed communication channels with regulatory agencies
  • Well-designed and easy-to-use interface, bilingual in Chinese and English, switching at any time
  • Industry's first functional modules such as dossier acceptance
  • High-level system integration, eliminating redundant installations and operations
  • Highly cost effective - taking advantage of package pricing on the CR Medicon platform
  • Process led by former FDA reviewers, providing guidance and reviews at each step
  • One-stop service across training, support, technical consulting and regulatory registration
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