Regulatory Affairs Submission

Milestone Submissions

  • IND Submission
    • IND Preparation and Submission
    • IND Amendment
    • Annual Report / DSUR
  • NDA/BLA Submission
    • NDA/BLA Preparation and Submission
    • NDA/BLA Amendment
    • Annual Report

Meetings with Health Authorities (Meeting request, Briefing package, and Meeting attendance)

  • Pre-IND Meeting
  • End of Phase I Meeting
  • End of Phase II Meeting
  • Pre-NDA Meeting
  • Pre-BLA Meeting
  • Other type A/B/C Meetings

Expedited Programs

  • Fast Track Designation (FTD)
  • Breakthrough Designation (BTD)
  • Regenerative Medicine Advanced
    Therapy Designation (RMAT)

Special Submissions

  • Orphan Drug Designation (ODD)

And More

  • Client specific regulatory affairs support
  • In-house eCTD submission
  • Safety reports, DSURs, PSURs
  • GLP, GMP, and GCP compliance

Solutions

Strategy Development

Strategy development is essential to overall product development and achieving the fastest regulatory pathway to approval. At Aleon, we customize the best strategy suitable to your needs by utilizing our expertise in the field of regulatory affairs. This will ensure that your drug product value is maximized.

Gap Analysis

Gap analysis is critical to ensuring compliance with regulatory requirements. Our team will analyze your current development status and provide strategic regulatory guidance for you to smoothly move your program forward and achieve faster regulatory approval.

Due Diligence

Aleon’s complete Due Diligence Analysis report include but not limited to the following aspects:
  • Product portfolio
  • Regulatory affairs status
  • Market potential
  • Company competitiveness

We will give you a comprehensive understanding of the program which can help you make a better decisions in evaluation and acquisition.
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