Case Study

Case Study: IND Preparation and Submission - Fast-Track Re-Submittal of pre-IND

Source: Camargo Pharmaceutical Services

Click Here To Download:
Product Sheet: Regulatory Consulting and Review
Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks

New Page 1

Challenge Prepare and submit an FDA guidance-compliant pre-IND package
Details When our client's pre-IND submission was refused by the FDA, Camargo was engaged to quickly prepare and submit an FDA guidance-compliant pre-IND package. Camargo's team of regulatory experts tackled the task and completed it within three weeks. In addition to bringing top-notch medical writing, data analysis and research skills to the project, we understand FDA reviewers' requirements and the appropriate methodologies for each type of application.
Value Thanks to FDA acceptance of the pre-IND package prepared by Camargo, our client was able to proceed expeditiously with drug development. Meanwhile, in the course of reviewing the documents, Camargo had discovered that several clinical studies included in the proposed IND budget were redundant and unnecessary. Elimination of these studies resulted in savings for our client of approximately $200,000.

Click Here To Download:
Product Sheet: Regulatory Consulting and Review
Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks