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Guides and Checklists

Explore our industry-leading guides and checklists to help you on your product development and commercialization journey.

Inspection Readiness ProgramDownload
Fast-Tracking Innovation: A Guide to Leveraging the 505(b)(2) Pathway to Accelerate Drug DevelopmentDownload
Target Product Profile Checklist: Laying the Foundation for Early-Stage AssetsDownload
Building Flexibility into Your Medical Device Launch StrategyDownload
5 Steps to Planning and Executing IND-Enabling Nonclinical StudiesDownload
Early Planning to De-risk Development: Nonclinical Strategy and Study DesignDownload
A Guide to Successful EU Marketing Authorization SubmissionsDownload
Developing Digital Medicines and Digital Therapeutics: Five Steps for SuccessDownload
IVDR Survival Guide: Understanding the IVDR Product Classification System and Complying with the New Clinical Evidence and Performance ExpectationsDownload
A Guide to In Silico Modeling and SimulationDownload
Addressing 505(b)(2) Product Development Challenges Before They Become ProblemsDownload
Using Real-World Data and Real-World Evidence to Support Rare Disease ProgramsDownload
A Quick Guide: Leveraging Target Product Profiles to Optimize Portfolio PotentialDownload
What is 505(b)(2)? Guide
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Regulatory Strategy Guide for Working with the FDA vs. the EMADownload
GxP Quality Guidelines and Regulations: Frequently Asked QuestionsDownload
Your NDA Preparation Should Have Started by Now: Checklist for Planning and Managing Your NDA Submission
Download
You Have a Product – Now What? Checklist of Key Considerations for an Effective Commercial Strategy
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505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, and Controls with Clinical Trial Phases
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Product Development Checklist: Navigating the Four Critical Stages of the Drug Development Process
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Succeeding with the FDA: Answers to Seven Common Questions About IND Submissions
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