OTC PHARMACEUTICALS / FDA
Drug product
compliance.
A clear path.
For complex products.
FDA regulatory support for pharmaceutical and over-the-counter drug products.
Pathway Register Represent Import
01 / PHARMACEUTICALS
Choose
your pathway.
Product characteristics inform the regulatory route.
01 / FDA
IND & NDA Support
We assist clients with pharmaceutical regulatory requirements, including Investigational New Drug (IND) and
New Drug Application (NDA) pathways.
02 / FDA
OTC & Innovative Products
OTC products must comply with applicable current monographs. Innovative products may fall outside established
categories or into more than one category. We outline the factors involved so you can make informed pathway
decisions.
02 / PHARMACEUTICALS
Register
your establishment.
Support for domestic and foreign drug establishments.
01 / FDA
Drug Establishment Registration
Domestic and foreign establishments that manufacture, prepare, propagate, compound, or process drugs must
register with FDA. We help clients understand the registration requirements relevant to their operations.
03 / PHARMACEUTICALS
Your U.S.
point of contact.
A U.S. representative for foreign establishments.
01 / FDA
U.S. Agent
Foreign establishments that manufacture, repack, or relabel drug products for import to the United States must
register with FDA and identify a U.S. Agent. The agent maintains a U.S. address and serves as the facility’s
representative before FDA.
04 / PHARMACEUTICALS
Prepare
for import.
Registration information matters at the border.
01 / FDA
Import Readiness
Every importer of drug products into the United States must provide FDA with the registration number of the
foreign manufacturer, repacker and/or relabeler. Failure to provide this information can result in detention or
refusal of the products.
CONTACT US
Plan your
next step.
Discuss your product, regulatory pathway, and U.S. market needs with Provision Consulting Group.