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Regulatory Affairs

National Medical Products Administration (NMPA) Services

Aleon has supported many pharmaceutical companies in achieving NMPA milestones, including small molecules, antibody, bispecific antibody, recombinant protein, ADC, nucleic acids, CGT and combination products, etc. In addition, we have also achieved 10+ simultaneous NMPA and FDA IND submissions with great success. Our experienced team is familiar with translating documents and utilizing OUS clinical data to ensure regulatory success.

Meetings with Center for Drug Evaluation (CDE)

  • Type I Meetings
  • Type II Meetings
  • Type III Meetings

INDs and NDAs/BLAs

  • IND Preparation and Submission
  • NDA/BLA Preparation and Submission
  • DSURs
  • Gap Analysis for CMC, Nonclinical, and Clinical Data
  • Amendments

Expedited Programs

  • Breakthrough Therapy Designation
  • Conditional Approval Designation
  • Rare Disease Program
  • Priority Review and Approval

Regulatory and Medical Writing

  • Investigator's Brochure (IB)
  • Study Reports

eCTD Publishing and Submission

  • INDs/NDAs/BLAs
  • IND/NDA/BLA Amendments
  • DSURs
NMPA development process diagram