Is your current process for managing abbreviated Prescribing Information (aPI) exposing you to an unnecessary compliance risk?
Many companies struggle with the short timelines and subject matter expertise required to create or update the aPI for their promotional materials. Challenges with version management, channel-specific formatting and content can put companies at risk for serious compliance deviations, so it is critical to ensure that the process is robust and efficient.
How can Pharma Integrity support you?
Pharma Integrity offers a comprehensive aPI service to cover the creation, review and update of these important documents. We work with you to establish a seamless process to ensure that you meet all internal deadlines and are confident with the finished product. We also review existing aPIs in circulation to ensure that they meet the current requirements and identify any unnecessary content which may be edited to save on space, without compromising patient safety.
Benefits
- Accelerate content availability: Eliminate bottlenecks in content approval due to delayed aPI updates
- Create consistency: Guarantee that aPIs across different brand teams are of consistent standard and format with an objective creation, review and update process
- Safeguard patients: Ensure all promotional material contains aPIs with the necessary safety information required to ensure compliant promotion to HCPs
What our clients say
“Pharma Integrity provide an excellent review service for API updates. This added layer of third party review ensures SPC updates are implemented appropriately to our APIs and internal compliance & code requirements are maintained. This oversight has streamlined our review process and ensures robust review for all API updates.”
Therapy Area Head