Eunomia helps pharmaceutical and biotech teams plan US compliance operations, connecting federal and state requirements with review, engagement, monitoring and reporting workflows.
Bespreek deze dienst
Lokale expertise · Wereldwijde uitvoering
For international pharma teams preparing US commercial activity, emerging biotechs building compliance processes and compliance leaders coordinating multiple states, products and third parties.
US requirements span federal law, FDA rules, programme integrity, transparency reporting, industry commitments and state laws. A national SOP may miss state-specific reporting, marketing-code or HCP interaction requirements.
Van vereisten naar actie
We can map planned activities to applicable requirements, identify state-specific questions for legal review and translate agreed controls into SOPs, approval routes and monitoring. Support can include promotional review coordination, HCP engagement and payment workflows, reporting checks, training and automation. Eunomia identifies Karen Glade as its Global Compliance Business Partner for the United States and Canada; confirm scope and specialist support before engagement.
Wat wij kunnen oppakken
Wat dit u oplevert
Toepasselijke vereisten (United States) verwerkt in uw wereldwijde processen
Duidelijke verantwoordelijkheden voor beoordeling en escalatie
Lokale ondersteuning zonder onnodige vaste bezetting
De regels: United States
Een korte gids met de belangrijkste wettelijke en zelfregulerende kaders. Elke samenvatting verwijst hieronder naar de officiële bron.
FDA rules require advertising to be truthful and non-misleading, with risk information in fair balance with benefit claims. Claims must be consistent with approved labeling and supported by appropriate evidence. Build review, reference checks, version control and applicable submissions into the workflow.
FTC guidance requires health-related advertising claims to be truthful, not misleading and adequately substantiated before dissemination. Review campaign net impression, including digital content, testimonials and implied claims, and retain supporting evidence.
The federal Anti-Kickback Statute prohibits knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or reward referrals involving items or services payable by a federal healthcare programme. Assess arrangements on their facts; written terms, legitimate need, appropriate compensation and evidence of services are useful controls. Obtain legal advice where required.
Applicable manufacturers and group purchasing organisations report specified payments to covered recipients and certain physician ownership interests through CMS Open Payments. Applicability depends on statutory definitions. Build recipient validation, reconciliation, correction, attestation and records into the annual process; CMS thresholds change each year.
The PhRMA Code is an industry commitment for companies that adopt it, not a federal statute. States may add conduct, registration, training, audit or disclosure obligations. Massachusetts, for example, requires covered manufacturers to register, follow its marketing code, train relevant staff, conduct annual audits and submit reports. Maintain a state-by-state assessment.
Dit overzicht is uitsluitend informatief en vormt geen juridisch advies. Reikwijdte en toepassing dienen te worden bevestigd voor de betreffende organisatie, markt, activiteit en wederpartij. Bronnen gecontroleerd in september 2026.
Vragen en antwoorden
No. FDA says pre-approval is generally not required, subject to limited exceptions and specific requirements. Companies remain responsible for compliant content and applicable submissions.
No. States may impose additional conduct, registration, training, audit or disclosure rules. Assess states where the company, agents and activities operate.
This guide does not claim a US office or formal regulatory appointment. Eunomia identifies Karen Glade as its Global Compliance Business Partner for the United States and Canada. Contact us to confirm expertise and delivery arrangements.
We luisteren, stellen een paar vragen en adviseren de juiste aanpak – vrijblijvend en zonder druk.
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