For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities…
The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate…
The US FDA Drug Establishment Registration is a mandatory requirement under 21 CFR Part 207 for all facilities engaged in the manufacturing, repacking, relabeling, or distribution of human and veterinary…
In the highly regulated pharmaceutical and healthcare industry, compliance with the U.S. Food and Drug Administration (FDA) is not optional it is a business necessity. When drug products are found…
Pharmaceutical companies must ensure the safety and effectiveness of their products even after FDA approval and U.S. market entry. This ongoing responsibility is managed through post-market reporting and pharmacovigilance programs,…
Over-the-counter (OTC) drugs play a vital role in the U.S. healthcare market, allowing consumers to access safe and effective treatments without a prescription. To ensure public safety, the U.S. Food…
Importing Active Pharmaceutical Ingredients (APIs) and finished drug products into the United States requires strict compliance with U.S. Food and Drug Administration (FDA) and U.S. Customs & Border Protection (CBP)…
For FDA-regulated industries such as food, cosmetics, dietary supplements, and pharmaceuticals, preparing for an FDA inspection is essential to ensure uninterrupted market access. Inspections are designed to verify compliance with…
The US FDA Drug Listing process is a mandatory compliance requirement for all human and veterinary drug products marketed in the United States. Under 21 CFR Part 207, every registered…
Accurate and compliant drug labeling is one of the most critical requirements for marketing human and veterinary drugs in the United States. Under 21 CFR Part 201, the U.S. Food…