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

Data Integrity

Data Integrity

Every company knows the importance of maintaining accurate and complete data of a high quality over periods of time and across all different formats. Having a good data integrity plan is essential and can save an organization time, effort, and money all while providing the security that the organization is not operating and making decisions with incorrect or incomplete data.
Failure Mode Affect and Analysis

Failure Mode Affect and Analysis

FMEA is an acronym that stands for Failure Mode Effect and Analysis which is a method for determining any and all possible points of failure in a design, process, or product. This is a combination of Failure Modes, which is a way in which something could potentially fail and result in defects, and an Effects Analysis which determines the consequences of those failures. During this, failures are prioritized by how serious their consequences are, their frequency, and how they are detected. Failures are eliminated based on their priority, starting with the higher priorities.
The Investigative Process

The Investigative Process

When issues occur that have the potential to impact product quality, Quality Assurance Reports (QAR) are generated to determine what happened, why it happened, and how to prevent it from happening again. An investigation is launched to determine this and what the potential impacts are.
Antimicrobial Resistance: An Overview

Antimicrobial Resistance: An Overview

Evolution is the process of how a species changes over time in response to their environment. Often termed “Survival of the Fittest”, the topic was studied most famously by Charles Darwin. While it is present across all species, one of the biggest impacts it can make is the change in a microorganism’s genome to resist antimicrobial products. These are used to treat and cure infections and sterilize surfaces among others. For this reason, antimicrobial resistance (AMR) has become a global concern.

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