Aug 1, 2019 | Did You Know, Drugs, EASeNews, Medical Devices
The FDA requires firms that manufacture foods, pharmaceuticals and medical devices to register their facilities on an annual or biennial basis, depending on the product category. Keep in mind, FDA assesses a Medical Device establishment registration user fee annually....
Jul 2, 2019 | Did You Know, EASeNews
The Voluntary Qualified Import Program (VQIP) enables qualified importers of food and food products into the U.S. an expedited review and entry. However, meeting the stringent requirements of the VQIP program requires a thorough demonstration of documented safety of...
Jun 1, 2019 | Did You Know, EASeNews
EAS offers holistic and cohesive services for clients looking to submit GRAS and NDI submissions to FDA. From the assessments to design of early feasibility studies, ongoing study oversight with the Contract Research Organization, strategy meetings with FDA and the...
May 1, 2019 | Did You Know, EASeNews
Increasing usage of electronic methods to capture and produce critical data, which are subject to regulatory scrutiny led to the effect of Title 21 CFR Part 11. This part of the Code of Federal Regulations establishes the United States Food and Drug Administration...
Apr 1, 2019 | Did You Know, EASeNews, Expert Witness
An effective Expert Witness is more than one who can write expert opinions, be deposed or provide testimony in court. Experts must represent your company accurately, independently and objectively in matters of legal proceedings and do so in a manner that enables them...
Mar 1, 2019 | Did You Know
Did You Know? Product development is more than just labeling, it is a holistic approach from ideation through commercialization that strategically looks at the category in which the product is intended to be marketed and those regulatory requirements surrounding it....
