What You Should Know About Regulatory Publishing And Submission
If your company has developed a new drug or medical device that you wish to submit to a regulatory agency, then you will know that the thousands of pages of paperwork and research required can take some time to gather. It can take extensive knowledge of the submission process, requirements, and regulations of the agency you wish to submit to.
This is where a regulatory submission and publishing service can help. They can take those thousands of documents and simplify the process of publication. Here is what you should know about regulatory publishing and submission.
Regulatory Submission And Publication
If you are a newer company, you might not have sent any data to a regulatory agency before. A regulatory submission is the process of submitting your data of a newly developed drug or medical product to a review board. If your company wishes to get advice or expert opinion on your new drug or product, sending in a submission can help a company gain this as well.
The Types Of Submission And Publishing
There are several different types of regulatory submission and publishing. You could submit information to obtain licensing to review medicines that have been developed, the review of medical devices created and more. It can be to begin clinical trials on new drugs or medical procedures recently developed.
You can also use a regulatory submission to modify existing medicines or medical devices and have them reviewed.
Things To Think About For Your Regulatory Submission And Publishing
Before you submit your data to a regulatory agency there are some factors to think about. First, do a background check to any agency you wish to submit to. Check out the department you specifically are submitting to, for example, the drug review department or medical device review department to see if it's the correct fit. Along the same lines, check what is required of you in order to submit to that agency.
Make sure you have all the relevant information you need to submit available and ready to send. If you are unsure of what to send, contact the agency and find out what content is required for the review. You also need to know how many copies you will need to send and how many you will need to have yourself for future reference.
Find out if you must send your submission electronically or if both an electronic and hard-copy submission is allowed for that agency. If you must submit electronically, then you must know which format is used.
For additional help, contact a global regulatory publishing service.