Expert in FDARegulatory Requirements
40 Years InRegulatory Profession
12 Year VeteranAt The FDA

Services

Expertise in resolving food, pharmaceutical, cosmetic and medical device problems; prepare response to FDA inspection reports involving GMP problems; plan and implement a proven approach to remove firms or products from FDA’s import alert system (automatic detention); insurance claims; drug firm registration & product listing; domestic and import compliance disputes. Seafood HACCP (Hazard Analysis Critical Control Point) plan review or preparation; seafood importer product spec sheet and method or verification development. Develop foreign supplier verification plan to comply with FDA 's new FSMA (Food Safety and Modernization Act) regulation.

Service

Regulatory Compliance

HACCP & FSVP Plan Development

Federal Agency Policy Review

Food, Cosmetic and Dietary Supplement Labeling

Product Development

Registration and Product Approval Issues

Cargo Surveying

Problem Resolution

What makes Pecora Consulting, LLC different than our competitors?

When you call Pecora Consulting LLC, you are calling the owner and consultant Richard Pecora; our projects are never farmed out to independent consultants. Pecora Consulting LLC, takes each and every client contact very seriously; whether it is to consult on a new product line, a time sensitive and/or serious Agency action, or to get insight on FDA or another Federal Agency, I am easily reachable via e-mail, chat, or telephone, 24/7.
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About us

Pecora Consulting, LLC at a glance...

About

Background

I am a regulatory consultant with extensive experience as a liaison to the Food and Drug Administration (FDA), and United States Department of Agriculture (USDA). With proven ability to assist foreign and domestic firms in a variety of regulatory and compliance matters. I have conducted training and seminars for professional trade groups and staff of Fortune 500 Company on regulatory issues. In over 40 years in the regulatory profession, my goal oriented approach has resulted in expeditious resolution of industry issues in a cost effective manner.

Our Approach

In over 40 years in the regulatory profession, our goal oriented approach has resulted in expeditious resolution of industry issues in a cost effective manner. Pecora Consulting LLC, core consultation is to domestic and foreign companies in understanding and complying with the rules and regulations of the Food and Drug Administration (FDA), and United States Department of Agriculture (USDA).

Methodology

The regulatory landscape is a harsh environment. With new, complicated regulations, FDA improvement and analytical advancements, it is now very difficult to conduct day to day business as a member of regulated industry. Pecora Consulting LLC is here to assist, guide, and advocate for you in dealing with any regulatory issue that may arise. To do this, we focus on our strengths and professional relationships to bring your problem to a satisfactory conclusion. Each consultation project is unique and each client receives a tailormade approach to solving the regulatory issue presented.

Problem Resolution 92%

Import Alert Petition Acceptance 98%

Drug Product Listing 100%

Some Fun Facts

FDA is responsible for the oversight of more than $2.5 trillion in consumption of food, medical products, and tobacco.

Fun Facts

Clients Worked With

738

Completed Projects

5321

Successful Appeals

4788

Will you be ready when the FDA comes?

An FDA or State Inspector may visit your operation for a variety of reasons, such as a routine inspection, an Agency Directed Program, a response to a reported problem or a sample collection and since they can come to your place of business at any time without prior notice, it is highly recommended that you be knowledgeable of your rights as a member of regulated industry.

If you do not agree with the actions being taken you should contact our office to seek guidance, speak with the inspector on your behalf to seek a resolution.

I have known Richard Pecora for at least 12 years. He is a thoughtful, caring, and knowledgeable regulatory consultant. I know when I call his office that he will be prompt in assisting in resolving my regulatory issues. He is also highly ethical and trustworthy. We continue to contact him for all our regulatory issues, and recommend him highly. Thanks for your continued assistance.

Bhavesh Oza

CEO, Dishman USA Inc

We have been working together with Pecora Consulting for many years and the experiences were all positive, the expertise in the field of business and the timeliness of problem identification and solving has given us a peace of mind and ultimately able to provide better service to our customers.

Donny

Senior Sales Manager - Shrimp Commodity, PT Central Proteina Prima, TBK

My only regret is that I wish I could have met Richard 10 years sooner! Simply put, Richard’s expertise with FDA regulations, protocol & the inner workings of this agency have allowed us to penetrate new markets & products faster than at any time in my 26+ year career in the chemical industry. As a direct result of my relationship with Richard, our revenues have increased significantly and most recently we are starting a new division which, in part, is a direct result of what I have learned over the years from having Richard on my team.

RCK

President AVF, LLC

Contact Us Today

Email us with any questions or inquiries or call 908-928-1706. We would be happy to answer your questions and set up a meeting with you.

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