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
When
Product Development
Regulatory Submissions
Post Market Compliance
Manufacturing and Distribution
Why
Regulatory Strategy
Quality System Development
Quality System Implementation
EMMA OnDemand
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COVID-19
EU MDR and IVDR
MDSAP
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Full Circle Consulting Resources
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.
The FDA has recently been putting a much greater emphasis on working smarter not harder when conducting clinical trials. Types of clinical trial designs called Complex Innovative Trial Designs (CIDs) which come in response to the rapidly changing drug development environment have recently been getting a lot of attention. These designs allow clinical trials to answer more questions in less time.
Maintenance of equipment is always essential to any manufacturing process. Breakdowns can wreak havoc on any process and can cause all kinds of issues for the manufacturer. Therefore, being able to perform regular maintenance on equipment that is prone to breaking down, has areas/processes that are at high risk of malfunctioning, or is extremely essential to the process before it breaks down allows for time and cost savings as well as maintaining product quality. This is known as Preventive Maintenance (PM).
Prior to drugs being commercially available, manufacturers often conduct pre-clinical studies to obtain data ensuring that their drug is both safe and effective. Once the data has been collected, manufacturers then submit an Investigational New Drug Application (IND) to the Department of Food and Drug Administration (FDA). Per the FDA, “An IND is a request from a clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans”.
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