For companies manufacturing, repacking, relabeling, or distributing human and veterinary drugs, annual and ongoing compliance with the U.S. Food and Drug Administration (FDA) is a mandatory responsibility. Non-compliance can lead to penalties, product recalls, import alerts, and loss of market access in the United States.

XPRO America specializes in providing Annual & Ongoing Compliance services to ensure pharmaceutical businesses remain aligned with FDA regulations year-round. Our expert support helps companies maintain drug establishment registrations, update drug listings, and stay informed of evolving FDA requirements.

Compliance does not end after initial registration it is an ongoing obligation. The FDA requires companies to renew and update critical information regularly, and failure to do so can cause severe disruptions to business operations. At XPRO America, we offer comprehensive compliance management tailored to your business needs, including:

• Establishment Registration Renewal: Ensuring timely renewal of FDA drug establishment registrations to prevent lapses that could lead to suspended operations or import holds.
• Drug Listing Updates: Managing updates to the National Drug Code (NDC) database through Structured Product Labeling (SPL) submissions, covering any new formulations, packaging, or discontinued products.
• Regulatory Monitoring: Continuously tracking updates in FDA regulations, guidance documents, and enforcement trends to keep your compliance strategy up to date.
• Ongoing Advisory Support: Acting as your compliance partner to answer FDA queries, prepare documentation, and assist with inspections or audits.
• Risk Mitigation: Helping companies avoid costly compliance errors by proactively identifying potential gaps and implementing corrective actions.

With XPRO America, companies gain confidence that their regulatory requirements are not only met but also strategically managed to support long-term success. Our goal is to reduce compliance risks while enabling uninterrupted access to the U.S. market.

Partnering with us means your company can focus on innovation and business growth while we handle the complexity of FDA compliance renewals, reviews, and updates.

XPRO America ensures FDA compliance with registration renewals, drug listing updates, and ongoing regulatory monitoring for pharmaceutical companies.