Our Experience
Our Experience
Our Experience
Drew Badger, PhD, DABT is the President of DAB Consulting and has 23+ years of industry experience in regulatory strategy and toxicology. Drew has provided global regulatory strategy and toxicology support for large and small molecule programs spanning pre-IND to market application/approval phases at large, mid-size and small companies. D
Drew Badger, PhD, DABT is the President of DAB Consulting and has 23+ years of industry experience in regulatory strategy and toxicology. Drew has provided global regulatory strategy and toxicology support for large and small molecule programs spanning pre-IND to market application/approval phases at large, mid-size and small companies. Drew is also the former President of the American Board of Toxicology as well as the American College of Toxicology.
Why Us?
Our Experience
Our Experience
The DAB Consulting team have extensive experience as primary authors and strategic leaders of numerous regulatory submissions including pre-IND meetings, IND's, End-of-Phase 2 meetings, Type C meetings, pediatric submissions, and global Clinical Trial Applications, among others.
DAB Consulting Scope of Services
Regulatory Support
- Serve as authorized regulatory representative for FDA and facilitate all correspondences / submissions
- Author, advise on content, or review of regulatory submissions
- Provide project management support of submissions (e.g., establish roles & responsibilities and maintain timelines for document author / review / publishing / submission)
- Provide full regulatory operations support, including document formatting, PDF processing, eCTD submission publishing, and lifecycle maintenance of INDs in eCTD format
- Provide post-IND filing support (e.g., response to FDA requests for information, advice letters, safety reporting, FDA meeting preparation, etc.)
- Advise and interpret regulatory guidance
Toxicology Support
- Design / review IND-enabling toxicology program and Scope of Work for CROs (avoid inadvertent hidden up-charges)
- Toxicology study monitoring at CRO’s
- Review of IND-enabling study protocols and reports
- Author, advise on content, or review nonclinical section of IND
Additional Services Offered
- Support due diligence activities
- Author, advise on content, or review Investigator Brochure
- Provide project team meeting attendance and presentations
- Prepare tabular summaries for regulatory submissions (if not already prepared by CRO’s)