MIAMI, Sept. 17 The U.S. Food and Drug Administration (FDA) now requires that establishment registration and drug listing information be filed in electronic format. The new requirement involves a 14-step account set-up process, followed by a specially formatted internet submission. VPCI (Vectech Pharmaceutical Consultants International) has received account activation from the Electronic Submission Gateway and is compliant with the registration requirements to file on behalf of its clients.
Pharmaceutical businesses, both foreign and domestic, which manufacture, prepare, distribute, compound, or process an FDA-controlled drug substance must file an annual establishment registration and list their drug products. Prior to the upgrade in June, those reports were filed in a paper-based format. The FDA hopes that the new electronic filing format will improve the timeliness and accuracy of the establishment registrations and drug listings.
"We're pleased to offer this service for the Pharmaceutical industry," said Craig Kruman, CFO and Director of Regulatory Administration for VPCI. "We are always looking for ways to help make things easier for our clients, especially those foreign locations that may not be familiar with the FDA registration process. The electronic account approval process is very specific and surprisingly complicated. Having been approved by the FDA, electronic filing is yet another service we can now provide to our clients."
VPCI, Inc. (Vectech Pharmaceutical Consultants International) (www.vpcint.com) is a Pharmaceutical consulting company offering FDA regulatory guidance, manufacturing technology support and high-level business development services. With scientific and technical experts on a global scale, VPCI has the ability to communicate with clients and regulatory agencies in a number of languages, strictly following good manufacturing practices (GMP).
Craig L. Kruman
CFO and Director of Regulatory Administration
Phone: +1 (248) 538-5150
SOURCE VPCI, Inc.