Eunomia helps pharmaceutical and biotech teams plan US compliance operations, connecting federal and state requirements with review, engagement, monitoring and reporting workflows.
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Conhecimento local · Execução global
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.
Dos requisitos à ação
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.
O que podemos assumir
O que ganha com isto
Requisitos aplicáveis (United States) integrados nos seus processos globais
Responsabilidades claras de revisão e escalonamento
Apoio local sem custos fixos desnecessários
As regras: United States
Um guia breve dos principais enquadramentos legais e de autorregulação. Cada resumo remete para a respetiva fonte oficial abaixo.
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.
Esta visão geral tem caráter meramente informativo e não constitui aconselhamento jurídico. O âmbito e a aplicação devem ser confirmados para a organização, o mercado, a atividade e a contraparte em causa. Fontes verificadas em setembro de 2026.
Perguntas e respostas
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.
Vamos ouvir, fazer algumas perguntas e recomendar o âmbito certo, sem compromisso nem pressão.
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