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
Quality System Development
Quality System Implementation
Post Market Compliance
ISO Standards Consulting
Operations
Product Development
Manufacturing & Distribution
Regulatory
Regulatory Strategy
Regulatory Submissions
EU MDR and IVDR
Featured Services
Project Management
Staff Augmentation
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Full Circle Consulting Resources
The National Institute of Occupational Safety and Health (NIOSH) was established in Section 22 of the Occupational Safety and Health Act of 1970. NIOSH began operations in 1971, a year in which the first toxic substances list was published. Since their initiation, NIOSH has grown to not only be a governance body but also a research institute. They are usually at the forefront with other federal departments when human safety is a main risk. Some examples of past human safety risks are the 2001 anthrax attacks, the 2009 H1N1 influenza pandemic, and most recently the Sars-Cov-2 pandemic.
The Food and Drug Administration (FDA) regulates a variety of product categories from infant and toddler foods to snacks to vegetables and meats. One category that falls within the food regulations umbrella is dietary supplements. Dietary supplements are defined to have an intention to add or supplement the diet and are different from conventional foods. Common supplements are vitamins, minerals, botanicals/herbs, botanical compounds, amino acids, and live microbials.
The wonderful thing about Quality is that it is industry agnostic. While certain industries, such as medical device and automotive, do have “special” requirements, the foundation of a Quality Management System is the same industry to industry. Obtaining ISO certification can be more than just a badge of honor for your organization, more and more customers and regulatory bodies are requiring ISO certification, which is why it’s more critical now than ever to consider it for your business.
Projects and staffing needs can change quickly. The market for high quality talent has never been more competitive. Staff augmentation is an easy and resourceful way to maintain your timelines and stay on budget. By relying on staff augmentation, you can easily outsource workers for staffing needs, timeline, outcomes, and objectives. Staff augmentation easily lets you scale up or down depending on your needs, eliminating the HR struggles of lay-offs, terminations, legal hassles, and documentation of full-time employment.
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