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.
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In April of this year, the FDA published two proposed regulations that, if finalized, would put limits on how much EtO can be used to sterilize products among other workplace/occupational hazard requirements. EtO, or ethylene oxide, is commonly used in the medical device industry to sterilize finished devices. Some examples of devices that are sterilized with EtO include gowns/drapes, heart valves, pacemakers, surgical drills, and catheters among many others.
Our hearts and prayers go out to everyone who has been impacted by the tornado that hit Rocky Mount, NC last Wednesday. First and foremost, we are happy that all of our Pfizer colleagues are safe after enduring this event. Pfizer reports that crews are working around-the-clock to assess the structural integrity of the buildings and to move medicine to nearby sites for storage.
Last week the FDA approved the first over-the-counter birth control drug. Opill, manufactured by Perrigo, is the first daily oral contraceptive that will be available without a prescription. The main constituent of Opill, Norgestrel, was originally approved for prescription use in 1973. The switch from prescription only to over the counter can sometimes be a complicated process, needing to take into account a variety of risks that the drug poses to public health. With the switch from prescription only to OTC, many other firms are beginning to review the possibility and implications of switching their own products from prescription to OTC.
Bingham Farms, MI, July 13, 2023 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting, has achieved ISO 9001:2015 recertification for its quality management system (QMS). Obtaining ISO 9001:2015 recertification reinforces EMMA International’s commitment to continuing to be a global powerhouse in FDA compliance consulting by consistently meeting and exceeding the expectations of our clients.
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