Our Compliance Program Design service helps pharmaceutical companies build robust compliance programs that meet regulatory requirements and industry standards. We design compliance frameworks for Sunshine Act reporting, anti-bribery and corruption (FCPA/UKBA), transparency reporting, and industry codes (PhRMA, EFPIA). Our programs protect your company while enabling legitimate business activities.
How our compliance program design service delivers value to your organization.
Comprehensive Sunshine Act compliance program including tracking, reporting, and aggregation methodology.
FCPA and UKBA compliance program design including risk assessment, policies, training, and monitoring.
Transparency reporting frameworks for US, EU (EFPIA), and other global markets.
Compliance with PhRMA, EFPIA, and other industry codes including interaction guidelines and review processes.
Comprehensive deliverables that provide actionable intelligence for your team.
A structured methodology that delivers results in four phases.
Assess compliance risks across operations, markets, and interactions.
Design compliance program including policies, procedures, controls, and training.
Support program implementation including training rollout and system deployment.
Establish compliance monitoring, auditing, and continuous improvement processes.
We cover Sunshine Act/Open Payments, FCPA, UKBA, EFPIA Transparency Code, PhRMA Code, Anti-Kickback Statute, False Claims Act, GDPR, and country-specific pharma compliance regulations.
Yes, we design global compliance programs with regional adaptation for local regulations, cultural considerations, and market-specific requirements.
Yes, we develop and deliver role-based compliance training including e-learning modules, in-person workshops, and certification programs.
Risk framework, risk register, and mitigation planning for pharmaceutical companies.
Learn moreSafety system design, signal detection, and risk management plans for pharmaceutical companies.
Learn moreGDPR, HIPAA, and data governance for pharmaceutical companies handling health data.
Learn moreConnect with our team to discuss how our compliance program design service can support your goals.
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