Boyce Consulting

contact us at:
cab@boyceconsulting.com

FDA's jurisdiction is diverse and broad reaching. Essentially, it encompasses any products that make claims which could affect consumer health. Sometimes product delineation is complicated. FDA is a regulatory agency whose legal actions range from widely publicized warning letters, to civil actions involving considerable monetary fines and penalties, to full blown criminal court charges.

You need qualified help to determine if your product or marketing claims comply with FDA regulations. You need our expertise to implement appropriate controls before production, before marketing, before FDA involvement.

To what extent are you liable for the marketing claims of your product?

If you are a small company, an entrepreneur or a large company which is involved with contracting design, manufacturing, packaging, sterilization, or labeling, distributing or importing, you need to have appropriate controls including appropriate contracts and specific delineation of responsibilities.

You need qualified help to identify loop-holes in your contracts and/or overall quality relationships which might be exposing you to FDA and FTC product liability issues.

How do you make contact with the FDA? Where do you start? Who do you call? What do you do first?

There are many approaches to getting started, some better than others. If you are already involved with the FDA, then there are various ways to get in compliance with the law.

Boyce Consulting specializes in saving time, money and headaches. We are committed to solving all your current regulatory concerns while preparing you and your staff to handle future FDA compliance issues.

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