Compliance and Regulatory Affairs

We work with you first to understand which regulations apply to your project and then to guide you on how to fulfill regulatory requirements.

Find Your Regulatory Path

Each type of product is subject to a unique set of regulations that can affect your timeline and your bottom line. It is important to know the answer to these regulatory compliance questions:

  1. Is your product regulated?
  2. Is more than one Federal Agency involved?
  3. Are registrations, certifications or submissions to Federal agencies required to legally market your product?
  4. Where should you start?
  5. Are there additional concerns for importers?

Notification & Petition Services

GRAS

New food ingredients must be either Generally Recognized as Safe (GRAS) or approved by FDA prior to market introduction. The GRAS notification process relies on published information whereas other petitions may include unpublished proprietary information.

NDI

Dietary Ingredients are components of dietary supplements. New Dietary Ingredients (NDIs) are those that were not in use in the US market as of October 15, 1994. FDA must be notified at least 75 days prior to market introduction of new dietary ingredients. FDA must also be notified of any claims made on dietary supplements within 30 days of use of the claim in the marketplace.

Registrations & Certification Services

Facility registrations for foods, supplements, cosmetics, drugs, and devices

All facilities, both domestic and foreign where foods, dietary supplements, drug and devices are manufactured, handled or held must be registered. Registration of cosmetic facilities is currently voluntary. Learn more about process registration.  Learn More

Process Filing for shelf-stable foods and beverages

If your food or beverage product does not rely on refrigeration/freezing or drying to maintain freshness, then the process used to maintain freshness and safety must be submitted to FDA for review.  Learn More

State Registration for Pet Foods

Pet foods must be registered in each State where they are sold. The requirements and forms differ from state to state.  Contact Us

EPA Registration of Certain Products

EPA registration is required for products intended to alter the environment or the creatures in it, including bacteria, mold and insects.  Contact Us

Medical Device Submissions

Medical devices must be reviewed and cleared by FDA prior to market introduction. We can help you with your medical device submissions.  Learn More

Claim Certification & Substantiation

Requirements

All claims must be truthful, not misleading, fair and supported by data. Some claims such as ‘organic’ and ‘gluten free’ are subject to specific regulations. In some cases, third party certification is the best.  Learn More

Liaison & Importer Services

FDA Liaison Services

  • Confidential Inquiries: From time to time you have a question for the FDA but do not wish to contact the agency yourself. We can confidentially ask your question of the agency and help you determine the best next steps for your project.
  • Meetings with the agency: Would it be best for you to meet with FDA to ensure you are on the right regulatory path?
  • Has your product been detained in customs?
  • Not sure what you need or afraid that what you need might be a game changer?

Services for Importers

  • Not only do imported products need to comply with the same regulations as those that are domestically produced, due to the inspection process, imported products are often held to a higher level of compliance and are also subject to some additional requirements.

We'll help you on the road to success.