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
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
•Product Sheet: Regulatory Consulting and Review
•Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks
| 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. |
•Product Sheet: Regulatory Consulting and Review
•Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks
This website uses cookies to ensure you get the best experience on our website. Learn more