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.
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).
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.
Docent Pharma provides the following assistance in Registration and Ingredient Statement filing for U.S/Non-U.S Cosmetic companies
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.
★ Development Stage Regulatory Support
★ Pharma Sourcing
★ Dossier/DMF/Regulatory Submission
★ Drug Labeling Review
★ Clinical & Non-Clinical Studies
★ Due Diligence
★ U.S. FDA Drugs Registration & Listing
★ U.S. FDA Outsourcing Facility/WDD/3PL
★ U.S. FDA GDUFA & Self-Identification
Docent Pharma Redefining the Global Regulatory Solutions and Services Landscape for Drug, BioPharma, Food, Medical Devices, and Consumer Healthcare Companies. Docent Pharma works in close collaboration with clients to provide innovative, reliable, customized & cost-effective solutions. The team at Docent Pharma consists of well qualified and dedicated staff with rich regulatory experience.
We Always Do The Right Thing, Not The Easy Thing
We Do Our Best At All Time
Generate New Ideas & Creative Approaches To Problems
We Achieve More By
Ask What The Customer Needs
Complete Tasks and Meet Deadlines
We Take The Initiative To Make Things Happen