Manufacturing and DISTRIBUTION

Consulting

Good Manufacturing Practices (GMP) change frequently. Partnering with a global compliance expert will ensure your manufacturing processes stay in compliance with Current Good Manufacturing Practices (cGMP).

EMMA International helps your organization implement and maintain the appropriate processes to support cGMP compliance for the highest level of product quality, safety, and strength. Backed by decades of cGMP experience, EMMA International has the experts on hand to not only manage your compliance project, but also facilitate manufacturing runs and remediate existing operations.

Contact us to find out how we can help your compliance needs.

Our Medical Device CMO

EMMA International proudly partners with New Concept Technology (NCT), a single-source supplier that offers expert design, engineering, process development, fabrication, and manufacturing services. NCT’s facility has a state-of-the-art class 100K clean room that is ISO 1464-1 Class 8 Certified. NCT is considered an expert in medical assembly. They also specialize in medical cable over-molding and medical process automation.

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Resources

The 10 Golden Rules for GMP Production – Part 1

Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards; for pharmaceutical production this is especially important. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 1 of a 2-part series that discusses the first 5 rules and why they are important.

The eSTAR 510k

The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) document that seeks to make 510(k) and De Novo submissions quicker and easier due to its automation from its form construction and autofill capability

Medical Device Reporting

Medical device reporting (MDR) is one of the post market surveillance tools used by the FDA to monitor medical devices’ performance post release (21 CFR part 803)

Artificial Intelligence and Machine Learning in Drug Development

With the growth of computational capabilities, artificial intelligence (AI) and machine learning (ML) have become a beacon of interest from both the product development side and the regulatory side. Implementation of AI and ML methodologies into the day-to-day life of our society is a real and ever-growing adaptive process. The FDA has just released a document that facilitates discussion and brings about important ideas for its place in society and how it will be regulated [1]. In 2021, over one hundred submissions to the FDA included some usage of AI/ML [2].

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