Rebel Compliance

Your Life Sciences Compliance Superhero.

OUR PRIORITIES

  • Helping clients to complete the Compliance tasks that may get delayed due to competing priorities or a shortage of resources.
  • Bringing creativity and simplification to Compliance materials.
  • Providing assessments and advice on meeting industry standards.
  • Training Compliance personnel on developing Compliance tools.

Services

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Assessments*

  • Compliance Program Assessments
  • Business Activities Risk Assessments
  • AdvaMed/PhRMA Code Assessments
  • Privacy Assessments
  • Process Assessments

Planning

  • Post-Assessment Improvement Plans
  • Prioritized Compliance Strategies
  • Annual Compliance Plans
  • Project Management
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drafting

  • Committee Charters
  • Policies & Procedures
  • Review and Approval Forms
  • Monitoring & Auditing Checklists
  • Compliance Reports

Operational Support

  • Compliance Program Development
  • Project-Based Assignments
  • Temporary / Fractional Support**

*We recommend that Risk Assessments be conducted in partnership with a law firm, such as Rebel Compliance Law, PC (a corporation in formation), to provide a legal analysis of any identified potential risks and to maintain attorney-client privilege.

**Rebel Compliance is available to support you to fill any temporary roles needed to operate your company’s Compliance Program.  Additionally, Rebel Compliance Law, PC (a corporation in formation), is available to provide fractional Legal support in areas such as materials review committees, due diligence reviews, and investigation or litigation support.

About

  • At Rebel Compliance, we are currently supporting pre-launch companies to establish their Compliance Programs and commercialized companies to operate theirs.
  • Sharon R. Delshad is a compliance generalist with over 10 years of experience supporting the life sciences industry.
    • Four years in-house as a compliance generalist and brand attorney* at small pharmaceutical companies.
    • Six years in the consulting divisions of PwC and Ernst & Young primarily advising life sciences companies under or expecting Corporate Integrity Agreements.
    • Three years as a contractor providing project management and litigation support to pharmaceutical companies.
  • In addition to Ms. Delshad, Rebel Compliance partners with other vendors and consultants to expand the scope of support  the Company can provide.

*Licensed to practice law in NY and NJ only. CA license approved and pending registration.

Rebel Compliance is not a law firm and we take the unauthorized practice of law seriously.  Where possible, we recommend a tri-party services agreement between your company, Rebel Compliance, and Rebel Compliance Law, PC (a corporation in formation), to simplify the transition between the legal and non-legal support provided by our different entities.