Investigational New Drug (IND) Enabling Studies
Welcome to the IND knowledge hub, your go-to resource for all things related to Investigational New Drug Enabling Studies and Approvals.
At Scientist.com we have worked with our industry partners to define research pathways and organizational requirements so that we can enhance the way we make connections with top service providers. Our helpful guided forms and Research Concierge team will assist you during every phase of your project and help you find high-quality partners.
Access our IND Specialty Research Area
For customized support and access to high-quality suppliers, start your purchase using our IND Enabling Study Package. This process allows you to source your project from start to finish, including CMC, DMPK, Toxicology and Pharmacology and offers exclusive discounts with these other benefits:
- Additional access to subject matter experts
- Professional guidance
- Proposal review and comparison
- Tracking and visibility into projects by compound for your whole team
- COMPLi approvals
- Animal Welfare
- GLP (quality)
- CMC
- Budget tracking for entire pipeline
- Schedule flexibility
- New suppliers
- Global access
Investigational New Drug Applications require a range of studies, which is why our IND Enabling Packages include multiple categories of work. Whether the work is preclinical (Toxicology, DMPK, Pharmacology, etc.) or Pharmaceutical Development & Manufacturing (aka CMC), you can access it all through our IND Enabling Package program.
Media and News Center
| FDA Investigational New Drug (IND) Application Guidelines |
| FDA Investigational New Drug Applications (INDs) for CBER-Regulated Products Guidelines |
| Keys to submitting a successful IND application to the FDA |
Best Practices for Submitting and Reviewing In Vivo Proposals
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