Looking for FDA Assistance? Let a former FDA Medical Officer help you.
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 was dissolved in 2010. Dr. Perkins continues to offer 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 510(k) submissions. These submissions have included both drug/device and biologic/device products. She 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. Dr. Perkins 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. Perkins has saved companies time and money with regulatory strategy.
Prepare for FDA inspection with "Mock FDA Audit"
Train your staff in GCP's, good clinical practices
at your site at your convenience.
Compliance issues prevent 483 or respond to 483
Negotiate with FDA at meetings prepare for Pre-IND
pre-IDE or 483 responses Get your first patient into your clinical trial
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