US FDA
The United States Food and Drug Administration
510k Approval
For legal commercialization of your product, 510k approval process need to be carried out by choosing the type of 510k and complying to the requirements established by the USFDA.
US Agent Service
For all Non-US organizations, who wish to sell their products in US market, will have to appoint US agent as a regulatory requirement.
FDA Food Facility Registration
Facilities that are situated outside the United States that manufacture, process, pack, or store food, beverages, or dietary supplements that are to be consumed in the United States are required to be registered with the U.S. Food and Drug Administration (FDA) by following the 12-steps process of registration.
FDA Drug Establishment Registration
As per 21 CFR 207, it is manufacturer’s obligation to register and to list their establishments with USFDA before marketing the drugs in the USA.
FDA Cosmetic Registration
Voluntary Cosmetic Registration Program (VCRP) is a reporting system of FDA for manufacturer/packer/distributor of cosmetic products to regulate cosmetics/ingredients distribution in the US.
HAVE YOU DECIDED TO TAKE THE NEXT STEP FOR YOUR QMS UPGRADE AND INTEGRATION? LET THE EXPERTS AT PAALAN INTERNATIONAL HANDLE IT:
PAALAN INTERNATIONAL specializes in medical device regulatory compliance.
Our consultants have assisted medical device companies worldwide with ISO 13485 QMS integration with 21 CFR and MDSAP.
A PAALAN INTERNATIONAL quality management system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets.
In addition to ISO 13485 consulting, we can assist with medical device licenses and establishment licensing in various countries
