Directory Image
This website uses cookies to improve user experience. By using our website you consent to all cookies in accordance with our Privacy Policy.

Get Assistance Meeting FDA New Drug Regulations

Author: Sara Moly
by Sara Moly
Posted: Sep 25, 2015

Know about FDA drug establishment registration by studying the rules and regulations for it online. Besides registering your drug establishment with the FDA, this service offers a wide range of assistance options to help you be in compliance with US FDA regulations.

If your business wants to market a new drug, there are important steps and guidelines to follow. Of course your drug must be registered with and approved by the FDA, whether they’re prescription or non-prescription drugs or over-the-counter drugs. You may get information about FDA drug establishment registration by studying the rules and regulations for it online. There are services available to help you get your drugs where you want them to go: in consumer’s hands.

At the site, you’ll find a wide range of free information regarding what will you need to get through the process, but on top of that free service, you can employ further services to help you get on track and to help you ensure you’re following FDA guidelines, which are very stringent. Some of the guidelines you’ll see are as follow:

Start by submitting a filled form which means you intend to bring a drug into the U.S. market. Our services can help you with include: facility registration/establishment registration for OTC drugs, drug testing laboratories, dietary supplements, homeopathic drugs, and Active Pharmaceutical Ingredients. You’ll also find the steps for FDA Drug Establishment Registration, which are: appointing U.S. Agent to complete FDA registration for foreign manufacturer; FDA Drug Establishment Registration fees and form completion, NDC label code, and drug listings. There are specific time frames for completing the FDA Drug Establishment Registration, and you must follow them carefully.

Besides registering your drug establishment with the FDA, this service offers a wide range of assistance options to help you be in compliance with US FDA regulations. This is a really helpful service for those companies not located in the United States that wish to market in that area. Drug rules and regulations are hard to get around in the U.S., and therefore you must be very careful about how you proceed. By choosing to use this valuable service, as well as take full advantage of the free tips available online, you can go a long way towards getting your drug on the market in the U.S. as soon as possible. At this web site, you’ll find all of the regulatory requirements, all information you need to know about FDA drug establishment registration, FDA cosmetic registration, Drug Master Files, GMP certificates, and much more. Anything you could possibly need to get your drug on the market according to FDA regulations can be found at this web site, and the service will take you right through the process. Don’t try to go at it alone when you have all of these valuable resources available to you. You don’t want to see that "Rejected" stamp on your registration, when, with a little assistance, you could’ve gone straight to "Approved."

Get your new drug on the market in the U.S. quicker than ever before with a little assistance from a valuable service that can help you meet and follow all Fda guidelines to the letter.

About the Author

If you are looking for Notified Bodies, then the author of this article recommends I 3 Consulting.

Rate this Article
Leave a Comment
Author Thumbnail
I Agree:
Comment 
Pictures
Author: Sara Moly

Sara Moly

Member since: Sep 25, 2015
Published articles: 12

Related Articles