Frequently Asked Questions

Q. What makes you an expert on FDA animal drug regulation?

A. Since 1993 my career has focused mainly on the regulation of animal drug products. Starting in 2011, I also help clients plan and prepare animal food additive petitions. My understanding of how the FDA does business comes from an insider perspective. During my fourteen year career as an FDA veterinarian, I served in a variety of positions within the Center for Veterinary Medicine. I have personally performed reviews of adverse events reports, promotional material, target animal safety protocols, effectiveness protocols for a wide variety of indications, data submissions, draft labeling, and Freedom of Information summaries for both food-producing and companion animals. I participated in policy development, drafted guidance documents, and chaired a group drafting new regulatory requirements. I hired, trained and supervised FDA veterinary review staff. I negotiated with representatives from large and small companies to define the specific safety and effectiveness requirements for approval of their products. And I represented the FDA in a variety of public forums to explain polices and answer questions. Since leaving FDA in 2007, I have continued to stay current by attending public workshops and conferences and meeting often with FDA on behalf of clients.

Q. What does “Master Reviewer” mean?

A. In the FDA career ladder for veterinarians there are two major pathways for promotion. One path is to become a supervisor. The other is to go through the Peer Review process. Master Reviewer status at the FDA Center for Veterinary Medicine is acquired through a formal peer review process. It is an acknowledgement that the candidate has, over a period of time, acquired extraordinary knowledge, skills, and abilities, has accomplished important work to advance the animal drug regulatory process, and is routinely performing duties that require an extra level of competence. I was promoted to Master Reviewer in 2001 and this is a point of pride for me. This accomplishment is comparable to specialty board certification in the field of Regulatory Medicine.

Q. Why is DOC Inc a good choice for my regulatory consulting needs?

A.     I am a regulatory enthusiast. I honestly enjoy my job. I like to help people. And I think this work is important. There are very few people in the world with a comparable amount of training and experience in this small specialized area.

When you visit a foreign country where you don’t speak the language, would you prefer to have a guide who makes occasional visits? Or, would you prefer a native guide who also speaks excellent English? Dealing with FDA is a lot like visiting a foreign country. FDA regulatory staff have their own language, culture, customs and taboos. To get the most out of your visit you need a guide. Most regulatory consultants learn the subject while working for a pharmaceutical company and making occasional visits. I “grew up” in that country. I speak the language and I understand the customs.

Q. What is your business philosophy?

A. I am an outdoor enthusiast and long-time LL Bean customer. I have adopted their policy of 100 percent satisfaction guaranteed: “You have our Word.®

The product that I sell is my personal service. There are no other employees at DOC Inc. If you are ever not satisfied with my performance, or a document that I have prepared, we can discuss the problem and I will do everything in my power to make it right. You have my word.