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