In 1984, after eight years as a medical officer at the Food and Drug Administration FDA, Dr. Jerri Perkins established Perkins & Perkins, Inc. PPI. PPI offers medical and regulatory assistance to the pharmaceutical and medical device industries. As president of PPI, she has written protocols, prepared companies to meet with FDA staff, participated in FDA meetings with companies, served on Data Safety Monitoring Boards, and assisted companies in preparing IND, NDA, ANDA, IDE, PMA and 510k submissions. These submissions have included both drugdevice and biologicdevice products. She has actively participated in regulatory issues involving AIDS, helped companies get their first patient into clinical trials, identified regulatory issues needing attention in submissions prior to FDA submission, and developed strategy for propelling a product from nonapproval to approval without additional data. In addition, Dr. Perkins has conducted preFDA audit inspections in the US and Europe. Her audit reports have been used successfully to prepare sites for FDA inspections.

Telephone: 301-983-0395
Website: http://perkinsandperkins.net/