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Compliance Governance Documentation

 

At the backbone of every Compliance Program is governance documentation that details the expectations and requirements for conducting business activities and interactions in a compliant and ethical manner. HELIO helps clients to develop and update key Compliance governance documentation including Policies and Standard Operating Procedures, as well as work instructions, call scripts, and FAQs. HELIO also assists with the dissemination and implementation of these documents to ensure availability and understanding throughout the business. Now, with HELIO AI, you can get immediate policy information and identify gaps in policies and procedures.

 

Services Include:

  • Policy/SOP Creation & Update

  • Industry Best Practices Advice

  • Industry Code Updates

  • Call Scripts, Guidelines, and FAQs

  • Process Flows

  • Roles & Responsibilities, Job Descriptions

CASE STUDY ONE:

Getting Two Companies on One Page

  • CHALLENGE

    A mid-size pharmaceutical company purchased another small pharmaceutical company and needed to integrate their compliance policies and processes.

  • APPROACH

    • Reviewed existing company policies from both companies

    • Addressed missing content or updates needed from both companies based on industry best practices/requirements

    • Drafted unified policies based on the needs of both companies

    • Assisted with training and communications of new policies and procedures across the organization

    • Identified areas of potential process integration risk based on policy updates and differences

    • Worked with various functional areas to update and integrate compliance-related or adjacent processes including HCP Engagement, FMV, sponsorships, grants, etc.

  • IMPACT

    HELIO’s assistance helped merge compliance related policies and processes from both companies to efficiently and effectively enforce compliant behavior in areas of high-risk.

CASE STUDY TWO:

Ready to Launch. All systems are Go.

  • CHALLENGE

    A small biotechnology company was in the process of launching its first product and standing up its Compliance Program in preparation for the increasing activities with healthcare professionals, healthcare organizations and government entities in the U.S. and globally.

  • APPROACH

    • Updated company’s Code of Conduct

    • Created Compliance policies addressing Anti-Bribery and Anti-Corruption, interactions with healthcare professionals and government officials

    • Created country-specific reference documentation outlining country laws and codes that provide guidance on interactions with HCPs

    • Developed HCP engagement process and relevant documentation and tools related to Needs Assessments and determination of FMV rates

    • Assisted with training and communications of new policies and procedures across the organization

    • Drafted numerous policy and SOP documentation to support high-level risk areas

  • IMPACT

    HELIO’s assistance helped to operationalize key policies and processes to mitigate potential Compliance and legal risks as the company prepares for launch.