Author: Emma International

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...