How We Help

Our experienced team of professionals strive to provide strategic-minded solutions that consider the regulatory environment while meeting the business objective.

Principal
Katie Graham

Katie Graham
EVP Regulatory Affairs

Regulatory Review

  • Assess internal and external scientific exchange, disease state, advertising and promotion materials based on interpretation and alignment with applicable Federal Laws, Regulations, FDA guidelines, product history, company policy, and current regulatory environment

  • Participate in Medical, Legal, Regulatory (MLR) Review Committee
  • Review and assess pre- and post-marketing strategies
  • Advise on interactions with OPDP
  • Preparation of 2253 packet

Medical Review

  • Assess scientific exchange, disease state, advertising and promotion materials and communications to ensure accurate representation of clinical and scientific evidence as required by the Code of Federal Regulations

  • Participate in Medical, Legal, Regulatory (MLR) Review Committee

  • Fact check scientific content within scientific exchange, disease state, and promotional materials

Reviewer Training

Half -day or full-day trainings on topics including:

  • MLR Regulations and Environment
  • Promotional Review Considerations of a Medical Reviewer
  • Regulatory Considerations in Advertising and Promotion
  • Here are the Boundaries: Considerations for Commercial Material Development
  • Medical Science Liaison Presence: Boundaries for Scientific Exchange

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Transformation through Collaboration