Clinical Trial Services
- Pharmaceutical companies are often ultimately responsible for adhering to cGCP requirements during the course of a clinical trial. While companies may assign Contract Research Organizations and/or Sites to perform part of these responsibilities on their behalf, delegations of responsibilities must be appropriately managed.
- The Firm helps manage such relations using appropriate and updated Master Services Agreements and Clinical Trial Agreements. The Firm also helps companies ensure that payments made to healthcare providers are representative of Fair Market Value and adhere to the requirements of the False Claims Act, Anti-Kickback Laws, Foreign Corrupt Practices Act and/or the Sunshine Act. The Firm can also audit Clinical Trial Programs to evaluate vulnerabilities and perform risk assessments.
- Pharmaceutical companies must ensure that their products are approved and sold in adherence to Good Manufacturing Practices and a variety of other laws and regulations. Failure to follow federal and state specific laws and regulations may expose the company to undue risk, including recalling their products.
- The Firm helps pharmaceutical companies adhere to the requisite standards of care and stay compliant. Services include registering with appropriate state agencies, engaging in confidential audits, setting up quality agreements, responding to FDA 483 audit findings and warning letters, and negotiating with the FDA regarding recall processes. The Firm can also serve as an expert witness in matters relating to compliance with FDA requirements.
Promotional and Non-Promotional Review Services
- Recent court rulings and settlements have potentially altered the acceptable bounds of promotional materials for approved and unapproved pharmaceuticals. The Firm assists companies to ensure that their review process remains compliant with current Good Promotional Review and Distribution Practices.
- Such services include reviewing potential promotional and non-promotional materials to ensure compliance with the FDA and a variety of other laws and regulations, including HIPAA/HITECH and the Physician Payment Sunshine Act. Additionally, the Firm can help with adding and amending appropriate Standard Operating Procedures and, if necessary, responding to titled and untitled letters relating to previously approved materials.
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