We are deeply saddened by the loss of such a great legal icon and scholar. Justice Ruth Bader Ginsburg, or the Notorious RBG as she was affectionately referred to by many, was a champion of justice and women’s equality. As a quality and regulatory consulting...
Bingham Farms, MI, August 12, 2020 –Inc. magazine today revealed that E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting has been named on its annual Inc. 5000 list, the most prestigious ranking of the...
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...
Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how...
Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes...
E.M.M.A. International Consulting Group, Inc. Announces New Advisory Board Farmington Hills, MI, January 16, 2020 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting for the Biotechnology, Pharmaceuticals, and Medical Device industries, is pleased to announce...
The process of creating, manufacturing, and marketing a medical device can be extremely difficult to navigate. Once you’ve done the engineering and know your device will work, what are the next steps? How do you take it from a prototype...
Clinical Decision Support Software is a tool that is utilized in making decisions for the diagnosis, treatment, prevention, cure or mitigation of diseases and other critical conditions. Such a tool provides clinicians, health care staff or patients with intelligently filtered...
Having a regulatory strategy to bring your device to the market may not seem like the most exciting part of developing a medical device, but it is one of the most important and can result in the most headache if...
If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to understand what role they play in making sure your device is compliant to the EU regulations. A Notified Body is an...