خبرة محلية · تنفيذ عالمي
لمن هذا الدعم
For international pharma teams preparing US commercial activity, emerging biotechs building compliance processes and compliance leaders coordinating multiple states, products and third parties.
Pharmaceutical compliance support in the United States
قواعد محلية مرتبطة بنموذجكم العالمي.
Eunomia helps pharmaceutical and biotech teams plan US compliance operations, connecting federal and state requirements with review, engagement, monitoring and reporting workflows.
ناقشوا هذه الخدمة معنا
التحدي العملي: United States
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.
من المتطلبات إلى العمل
كيف يمكن لـ Eunomia المساعدة
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.
ما يمكننا تولّيه
الامتثال الدوائي: United States: نطاق الدعم
تفسير المدونات المحلية والرد على الاستفسارات
مراجعة التعامل مع المهنيين الصحيين ومنظمات المرضى
متطلبات الشفافية والإفصاح المحلية
مراجعة المواد الترويجية وغير الترويجية
تقييم الامتثال لدخول السوق
تقييم متطلبات التخصص واللغة
ما تحصلون عليه
المتطلبات المنطبقة (United States) مدمجة في عملياتكم العالمية
مسؤوليات واضحة للمراجعة والتصعيد
دعم محلي دون كوادر ثابتة غير ضرورية
القواعد: United States
ما يشكّل الامتثال: United States…
دليل موجز لأهم الأطر القانونية والتنظيم الذاتي. يرتبط كل ملخص بمصدره الرسمي أدناه.
FDA prescription drug promotion
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.
Consumer health claims
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.
Federal HCP arrangements
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.
Open Payments
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.
Industry codes and state requirements
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.
المراجع الأساسية
هذه النظرة العامة للاطلاع فقط ولا تُعدّ استشارة قانونية. ينبغي التأكد من النطاق والتطبيق بالنسبة إلى المنظمة والسوق والنشاط والطرف المقابل المعنيّ. تم التحقق من المصادر في سبتمبر 2026.
أسئلة وأجوبة
الامتثال الدوائي: United States: الأسئلة الشائعة
Does FDA pre-approve every US promotional material?
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.
Does one federal process cover every state?
No. States may impose additional conduct, registration, training, audit or disclosure rules. Assess states where the company, agents and activities operate.
Does Eunomia have a US office or formal regulatory representative?
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.
أخبرونا بما لديكم على مكتبكم.
سنستمع إليكم ونطرح بعض الأسئلة ونوصي بالنطاق المناسب، من دون أي التزام أو ضغط.
ابدؤوا الحوار