FDA Listings
Proper FDA registration and product listing are essential for ensuring compliance and maintaining market access. At Sci Strive, we help businesses navigate the complex FDA listing process, ensuring all necessary registrations and submissions are completed accurately and efficiently.
FDA Listings
Facility Registrations
Certain types of businesses, including food, dietary supplement, drug, and cosmetic manufacturers, must register their facilities with the FDA. We assist with:
FDA Food Facility Registration under the Food Safety Modernization Act (FSMA)
Drug Establishment Registration for OTC drug manufacturers and repackers
Cosmetic Facility Registration for voluntary FDA compliance
Cosmetic Product Listings
Under the Modernization of Cosmetics Regulation Act (MoCRA), many cosmetic products now require FDA listing. We ensure your products are properly registered, covering:
Ingredient disclosures in compliance with FDA regulations
Verification of product classifications (cosmetic vs. drug)
Timely updates to stay compliant with evolving FDA guidelines
National Drug Code (NDC) Acquisition & Listing
For OTC drugs and other regulated pharmaceutical products, obtaining and listing a National Drug Code (NDC) is mandatory. We handle the entire process, including:
NDC number acquisition for new drug products
Proper formatting of Drug Facts labels
Submission and maintenance of NDC listings in the FDA’s database
At Sci Strive, we don’t just file paperwork—we ensure that your FDA listings are accurate, complete, and aligned with regulatory expectations so you can avoid compliance issues down the road.
Does this sound familiar?
- You’re ready to start selling OTC products but just found out your facility needs to be registered with the FDA.
- You’re expanding into the U.S. market but don’t know how to submit the required FDA product listings.
- You landed a big retail order, but your product requires an NDC number, and you’re not sure how to get one.
Don’t worry — we can help.