Biotech Research Group (biotechresearchgroup)
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Process of FDA approval for medical devices
Whether or not, a new drug requires FDA approval depends on whether it complies with an over-the-counter (OTC) monograph. To obtain it, drug manufacturers must conduct clinical tests in laboratories, animals and humans and send their data to the FDA.
about 2 hours ago from web -
Know about 510(k) Premarket Notification
510k submission is the appropriate pathway to the marketplace in the U.S. Knowledgeable and experienced 510k consultants, such as those at BRG, can guide companies/sponsors through the process and manage all submissions to FDA.
about 3 days ago from web -
Quality assurance consulting services
If you don’t have an internal quality inspection team, you can outsource Quality assurance consulting services at affordable prices. Quality inspection is the process of inspecting items, materials, products or services in the state and at the receiving stage. It can be done by your own factory or by a third party company.
about 13 days ago from web -
Benefits of Pharmaceutical consulting services
Identifying opportunities by hiring professional Pharmaceutical consulting services allow the pharmacy optimizing results, reducing costs, gaining customers trust and increasing income. These are some of the benefits that we can obtain from having a consultant by our side.
about 15 days ago from web -
Consultants for FDA 510k submissions
One of the first steps in selling a Class 2 or IVD medical product in the USA is to submit a Pre-Market Notice, known as FDA 510k to the FDA. Technically, the FDA does not approve medical products or IVDs for sale upon presentation of the 510k, but rather grants a clearance to be sold in the USA.
about 22 days ago from web -
Occupational Toxicology: know the importance
Toxicology is a science that aims to understand the interaction and the relationship of chemical agents with the organism under specific conditions of exposure and also serves to assess and monitor the toxic effects that this interaction can cause in organisms.
about a month ago from web -
Do you know what a pharmacy scientist does in practice?
If you did not know what a pharmacy professional does, know that the person trained in this area can work in several branches. It is the reason why the hiring process of a professional pharmaceutical scientist takes time and great skills. It would be better if you hire from a recognized organization.
about a month ago from web -
Know about US FDA ANDA
If you are looking for a way to get your new drug application to reach the stage of FDA then this is where you can get help from.
about a month ago from web -
Reliable medical device consulting services
Amid this global pandemic, the need for medical devices has increased at a very high level. But not every medical device is approved by the FDA and this is why you need the help of experts, who can help you get the best medical devices that are approved by the FDA. Usually most of the time, people do not care about the FDA approval, but it becomes illegal when someone gets access and uses medical devices that are not approved by the FDA.
about 2 months ago from web -
Pharmaceutical Consultants
BRG has an excellent reputation as a leading regulatory and scientific affairs consulting firm, which has clients and consultants in over 60 countries across the globe. The primary aim of BRG is to provide efficient and expeditious services and give the best solutions for our clients’ products that include pharmaceutical consulting, medical devices, healthcare information technology, and scientific services.
about 6 months ago from web -
Way to overcome FDA warning letters
Once after you are notified with FDA warning letters then you need to have an eye on all the things of the medical equipment. The inspection that made after the warning letter leads to be success FDA needs to assure the kit.
about 6 months ago from web -
Know about Regulatory Affair and Regulatory Compliance
Before a drug come into the market Regulatory affairs will check it and then alone assure. Be it is any sorts of products include pharmaceuticals, cosmetics, veterinary medicines, medical devices, pesticides, agrochemicals, and so on.
about 7 months ago from web -
Know about Quality Assurance Consultants Services for Pharma Industry
Quality assurance is one of the activities that help organizations in all possible ways. The consulting focuses the entire process to improve the quality products to deliver to customers. Quality assurance consulting gives better phases of the cycle such as plan, do, check, and act.
about 7 months ago from web -
Know about 510 K Premarket Notifications
Act 510 k premarket notification is one of facilitating the review, clearance, submission to the legal market device. These are a legal act that you can sell or distribute them easily.
about 7 months ago from web
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