At Nuventra we strive to help our clients and readers navigate the drug development process with ease. Our toolkits include articles, guides, checklists, cheat-sheets, relevant FDA guidances, and more to help make your drug development process a little easier.
Follow the links below to have any of our toolkits emailed directly to you.
Regulatory Publishing & Submission Toolkit
It is essential to thoroughly understand and adhere to all of the publishing and submission requirements and expectations that the FDA (or other regulatory authority) has laid out. In this toolkit you will find essential resources to help guarantee that your publishing and submission process is complete, timely, and fully meets regulatory expectations.
- Part 1: eCTD Submissions: Hints & Common Mistakes to Avoid
- Part 2: QC Checklist: Regulatory Submission Documents
- Part 3: Quick Guide to CDISC Standards: Consierations for Regulatory Submissions
- Part 4: 9 Tips for Preparing a Successful NDA
Clinical Pharmacology Planning Toolkit
To keep up with the fast-paced, and ever-changing world of drug development, it is critical to consider your clinical pharmacology plan early on in your program. In this clinical pharmacology planning toolkit, you will find three essential resources that will assist you in planning for a successful clinical pharmacology program.
- Part 1: Overview of the costs involved in your clinical pharmacology program
- Part 2: Clinical pharmacology planning timeline & template
- Part 3: FDA’s Question-Based Review document
Communicating with FDA Toolkit
Clear communication with the FDA can greatly increase the chances of getting your drug approved. In this toolkit, you’ll find five essential resources to improve your communication with the FDA. Benefit from first-hand experience and advice from Nuventra consultants Gene Williams and Iftekhar Mahmood, who both spent over 20 years as clinical pharmacology reviewers at the FDA.
- Part 1: Communicating Effectively with the FDA; Roles & Responsibilities / Dos & Don’ts
- Part 2: Questions & Answers with Former FDA Reviewers
- Part 3: Cheat Sheet: Meeting Types and Timing
- Part 4: Relevant Guidances from the FDA
- Part 5: Meet Nuventra’s Former FDA Reviewers
More toolkits coming soon…