Our nonclinical experts have over 30 years of experience in advancing therapies, and combined have successfully submitted:
43

IND/CTAs


7

NDAs


4

BLAs


6

EU MAA


Together, we understand that a well-designed nonclinical program will maximize your chances for clinical success.
PROGRAM / IND GAP ANALYSIS
Our expertise is in translating nonclinical science into key clinical trials.

Our Nonclinical experts can thoroughly review and assess the current state of your development with an IND gap analysis. This analysis will outline a plan to advance your program to IND as swiftly and efficiently as possible, preemptively identifying any potential missing projects or questions and preparing your program for a successful IND and key clinical trials.
NONCLINICAL STUDY AND PROGRAM SUPPORT
A well designed nonclinical development plan should mitigate risk and support the launch of key clinical trials that will lead to product approval. Whether you are needing technical writing assistance or strategic program support, we can help.

Not all drug development programs are created equal, especially in the rare disease industry. We understand it takes smart, concise delivery back by novel and often unconventional approaches. With extensive experience in orphan product development, regulatory interactions and over 40 successful IND’s, RareMoon’s experts consistently offer nonclinical support and strategies with confidence.

    Expertise Include:

  • Pharmacology
  • Metabolism
  • Pharmacokinetics (PK)
  • Toxicology
  • Bioanalytical

    Services Include:

  • Technical Writing
    • Preparation of nonclinical study reports
    • Preparation of nonclinical regulatory documentation
    • Preparation of SOPs
  • CRO Selection and Management
  • eCDT report preparation and management
INVESTIGATOR’S BROCHURE
An IB serves many purposed and is useful to all parties involved in your program’s development including investigators, stakeholders and regulatory agencies. It is multidisciplinary, will summarize the main elements of your entire development program and should be updated regularly.

The main sections of the IB will include:

    Summary:

  • Introduction
  • Physical, chemical, and pharmaceutical properties and formulation
  • Nonclinical studies
  • Clinical studies & human effects
  • Summary of data and guidance for use
A concise and focused presentation style is a challenge in preparing your IB. While it needs to be comprehensive, it also needs to be readable. Our experts have the experience required to comprehend data and information, and author IBs in a language that is both informative and concise.
Contact us to discuss your nonclinical development strategy and implementation.