What We Do

Grayscale Compliance can help you with review committee services, training (including LMS modules), analyses and consultations, and compliance monitoring or investigations.  Expert witness retainment also available on a case-by-case basis.

Therapeutic Areas and Products:

  • Gastroenterology

  • Cardiovascular

  • Oncology

  • Immunology

  • Dermatology

  • Vaccines

  • Blood products

  • Neuroscience

  • Respiratory

  • Nephrology

  • Endocrinology

  • Pain

  • General Care

Complex Issues:

  • Direct to consumer promotion

  • Health economic and comparative effectiveness

  • Scientific Exchange

  • Drug Safety Communications/REMS

  • Comparative clinical studies

  • Requests for Advisory Comments

  • Subpart H and Subpart E submissions and process

  • Social media and new and emerging technologies and media

  • OPDP and APLB enforcement actions

  • Enforcement patterns, intensity, and analysis

  • Competitive complaints

  • Document reviews and investigation support