BALTIMORE, May 29, 2020 (GLOBE NEWSWIRE) -- FDAImports.com, the premier regulatory firm for expediting the importation of highly-regulated products into the United States, announced today that the donation of its time, skills and networks has been a success. After suffering many weeks of regulatory confusion and delay, FDAImports.com helped Baltimore received a donation of 50,000 surgical masks from its sister city, Xiamen City in China. The donated masks were received by the Mayor of Baltimore, Bernard Young, in a brief ceremony during his daily COVID-19 update, earlier today.
“We have had great success in sourcing and vetting suppliers of PPE, test kits and drugs. We have also been very successful in expediting the importation of these items into the U.S. on behalf of PPE and drug manufacturers, importers and distributors,” said Benjamin England, CEO of FDAImports.com. “When we were asked to expedite the importation process to assist Xiamen City in delivering its gift of surgical masks to Baltimore, we were honored to help. We hope these masks will help frontline medical staff in reducing the exposure to, and spread of, COVID-19.”
Led by attorney Benjamin England, a 17-year FDA veteran, the FDAImports.com team has more than 100 years of in-house FDA experience in combination with extensive Customs and Trade Practice knowledge and experience. FDAImports.com leverages its team’s expertise to assist clients worldwide with navigating the highly-complex and technical pre-market approval, compliance requirements and importation rules of FDA, Customs, USDA and EPA, among many other U.S. agencies.
FDAImports.com represents medical device and drug companies from around the globe before the FDA and Customs on regulatory clearance, compliance and enforcement matters and facilitates the import process.
For the last six months, FDAImports.com, along with the affiliated law firm of Benjamin L. England & Associates, has turned its regulatory consultants and affiliated regulatory attorneys toward assisting medical device, PPE, COVID-19 test kit and drug manufacturers and importers. They have assisted clients with interpreting and complying with the rapidly changing Emergency Use policies and regulatory requirements.
Additionally, FDAImports.com has successfully connected the suppliers of PPE, test kits, and drugs to buyers, assisted with vetting regulatory compliance, ensuring labeling instructions and warnings are clear for medical staff to follow, importing the medical products and obtaining funding to bring these critical, life-saving materials into the U.S. Its capabilities enable FDAImports.com to arrange for due diligence, ensuring that the goods are what the buyer needs. It also works with other third-party logistics professionals to ensure that no inadvertent switching of goods occur during international transportation to the U.S.
FDAImports.com and its affiliated attorneys perform pre-market clearance work and vetting of suppliers of PPE and medicines, obtain clearances from FDA, ensure that labeling is compliant with registration – in addition to ensuring that other filings are performed correctly. Due to the COVID-19 pandemic, the FDA has formulated a series of expedited and relaxed programs to accelerate access to PPE and drugs needed by healthcare personnel and the public. FDAImports.com regularly engages with FDA and Customs to obtain emergency clearances and access to the U.S. market.
About FDAImports.com, LLC
FDAImports.com is the premier regulatory firm for expediting products to the highly-regulated U.S. market. Its team has more than 100 years of in-house FDA experience in combination with extensive Customs and Trade Practice knowledge. FDAImports.com leverages its team’s experience to assists businesses that need help in navigating the complex and highly-technical importation rules at FDA, Customs, USDA and EPA, among many other U.S. agencies. For more information, please visit www.fdaimports.com.
FDAImports.com, LLC is a private FDA regulatory consulting firm and is not the U.S. Food and Drug Administration.
Media Only Contacts:
Ed Schauweker
AVID Public Relation on behalf of FDAImports.com
ed@avidpr.com
703-963-5238
Anne Lehan
Director of Marketing and Business Development
FDAImports.com
aelehan@fdaimports.com