Let this former FDA Medical Officer take away the mystique surrounding the FDA!
After eight years as a medical officer at the Food and Drug Administration (FDA), Dr. Jerri Perkins established Perkins & Perkins, Inc. (PPI) in 1984.
Dr. Perkins continues to offer medical and regulatory assistance to the pharmaceutical and medical device industries. As President of PPI, Dr. Jerri Perkins 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 510(k) submissions. These submissions have included both drug/device and biologic/device products.
Dr. Jerri Perkins has actively participated in regulatory issues involving AIDS, helped companies get their first patient into clinical trials, identified regulatory issues in submissions prior to FDA submission, and developed strategy for propelling a product from non-approval to approval without additional data.
Dr. Perkins has successfully worked with pharmaceutical and medical device companies and saved sites from getting 483s, propelled non-approval products to market, helped get first patient into clinical trials, negotiated labeling issues and helped companies resolve 510k and PMA issues.
By asking companies the right questions, Dr. Jerri Perkins has saved companies time and money with FDA regulatory strategy.
Dr. Jerri Perkins professional services include, but are not limited to:
- Preparing for an FDA inspection with “Mock FDA Audit“.
- Training your staff in GCP’s, good clinical practices at your site at your convenience.
- Handling compliance issues prevent 483 or respond to 483.
- Negotiating with FDA at meetings, and preparing for Pre-IND, Pre-IDE or 483 responses.
- Early development for drugs and devices.