We Can Help You Plan Your IND-Enabling Program

Getting to first-in-human trials is the most critical and most scrutinized milestone in drug development. Our IND-enabling team combines 40+ years of GLP execution with regulatory scientists who have sat on both sides of the FDA advisory table, ensuring your program passes from day one.

Charles River Research lab technician, an African American woman wearing blue scrubs with a logo, working in a lab testing samples for the IND enabling program.

Your Clear Path to First-in-Human Approval and Beyond

Getting to first-in-human trials is the most critical and most scrutinized milestone in drug development. Our IND-enabling team combines 40+ years of GLP execution with regulatory scientists who have sat on both sides of the FDA advisory table, ensuring your program passes from day one.

1,500+

IND programs conducted annually

8,500+

GLP studies executed each year

> 80%

of novel FDA-approved drugs in the past four years supported by our services

  • ✓ End-to-end IND-enabling program design, sequencing, and execution
  • ✓ GLP and non-GLP studies with documentation aligned for submission
  • ✓ Real-time milestone tracking and visibility through Apollo™
  • ✓ Integrated bioanalytical and safety pharmacology support
Charles River histopathology technician working on slides for an IND program.

IND Enabling Services Brochure
Conquer IND hurdles with our comprehensive solutions. We work with you in lockstep and provide tailored solutions you need to expedite your drug development timeline.
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photo of lab tech in protective gear

Dispelling the “Cookie Cutter” Fallacy of Small Molecule IND
View this webinar to discover how to adapt your approach to your IND program’s unique challenges to gain a competitive edge.
Watch the webinar

H-Guard Priming anti-inflammatory solution in use for more efficient hemodialysis in patient

IND Success Through Nonclinical Strategy
See how integrated nonclinical and regulatory support helped Invizius secure MHRA approval to advance H-Guard® into first in human trials.
Read the case study

Our experts are available to help provide guidance throughout your program. Please provide us with more information about your requirements and we will contact you to discuss how we can support your journey to market.

  • Need regulatory advice? Our scientific advisory experts can help you outline your IND-enabling studies to meet your milestones and achieve the relevant data necessary to move into first-in-human clinical trials.
  • Have a question? We have answers and can offer solutions to your greatest challenges.
  • Want more information? We’re happy to explain our services, methods, and technologies in greater detail.
  • Is your project ready to go? Request a quote.

I have confidence in designing my pre-clinical packages with Charles River’s guidance. When you trust a contractor, making management decisions about timelines and costs, as well as getting Board agreement, is a lot easier.”

Dr. Magnus Nicolson, COO, Invizius H-Guard® MHRA First-in-Human Approval

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