Over-the-Counter (OTC) Drugs
Docent Pharma LLC provides US national brand-equivalent non-prescription/OTC drugs products to branded products. We are distributing our own affordable brand “Selff-Aid” non-prescription/OTC drugs products to Mail-Order Pharmacy, Independent Retail Pharmacy, National Chain Pharmacy, Independent Physician Practitioner, Grocery Store Pharmacy, Chain or Independent Convenience Store.
U.S.FDA Food / Beverages / Dietary Supplement/ Nutraceutical Registration
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires that all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the US register with the U.S. Food and Drug Administration (FDA).
U.S. FDA Medical Device Registration & Listing
The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial, or Updates) be submitted electronically unless FDA grants a waiver.
U.S. FDA Cosmetics Registration & Listing
Docent Pharma provides the following assistance in Registration and Ingredient Statement filing for U.S/Non-U.S Cosmetic companies
- U.S. FDA Voluntary Cosmetic Registration Program (VCRP)
- U.S. FDA Cosmetic Product Ingredient Statement (CPIS) Filings.
- California Safe Cosmetics Program (CSCP) Registration Requirements.
U.S. FDA Agent Services
The United States Food and Drug Administration (FDA) requires US Agents for foreign companies who wish to sell or involve in the manufacturing/testing of drugs or pharmaceuticals, medical devices, food, and dietary supplements, in the United States. US Agent also requires for foreign applicants who wish to file NDA or IND with the FDA. The US Agent acts as a communicator between the FDA and foreign companies.
