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Regualatory, Legal & Compliance

Regulatory pressure has shifted the responsibilities and accountability to medical affairs. Medical Affairs personnel understand the complex research behind the products and play a critical role in scientific exchange between the company and external Key Opinion Leaders. Policies outlining regulatory guidance and clarifying roles and responsibilities are very important to the organization. Practical compliance training is crucial to any organization as the government has heightened its scrutiny of drug promotion and medical communication. The FDA and OIG encourage pharmaceutical companies to utilize medical affairs personnel to facilitate effective and legally compliant interactions between the life science companies and healthcare professionals. Several corporate integrity agreements (CIAs) have stressed that the medical affairs function is an important compliance tool and requires control around medical information activities.

Click on "More Info" to view list of services for regulatory and compliance

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