Full Circle Consulting

EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.

Full Service

Full Circle Consulting

EMMA OnDemand


Quality System Development

Quality System Implementation

Post Market Compliance

ISO Standards Consulting


Product Development

Manufacturing & Distribution


Regulatory Strategy

Regulatory Submissions


Featured Services

Project Management

Staff Augmentation

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Full Circle Consulting Resources

Water for Pharmaceutical Use

Water for Pharmaceutical Use

When determining which type of water system is needed for pharmaceutical manufacturing it is important to keep in mind how the water will be applied to the product.
Investigational Device Exemption

Investigational Device Exemption

An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data....
Concepts of Modern Quality systems

Concepts of Modern Quality systems

A quality system's main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve...
How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.

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