Services
"They explore possibilities, stimulate creativity, and develop innovative solutions to difficult problems."
William G., AVP Medical Affairs, Top 5 Pharma Company
Medical Review Solutions
Whether your organization is looking for an ad hoc review, outside consult, or a fully integrated solution, a trusted partner can make all the difference in meeting your objectives, resource requirements, and business needs. We provide comprehensive medical reviews to ensure your organization efficiently approves compliant and compelling content by:
- serving as the Medical Promotional Reviewer supporting the review of both commercial and medical materials for assigned therapeutic areas and brands
- verifying and contributing to the medical and scientific accuracy of content and claims
- collaborating with stakeholders across Commercial/Marketing, Regulatory Affairs, Legal, and Compliance and engaging cross-functional solutions and recommendations
- providing medical insight and perspective into the development and direction of new and novel marketing campaigns and materials
- fully investing in your success and serving as an extension of your team
Training
Want your team to tackle medical review in-house?
We will provide your team with a series of customized, comprehensive, and specialized workshops covering the topics of substantial evidence, relevant FDA guidance documents, and enforcement letters so they can better understand the complex environment they find themselves in as Medical Reviewers. Additionally, we offer ongoing support and mentoring for team members to ensure their support and success as they navigate their position as medical reviewer.
We fully appreciate that medical review is more than understanding the science and regulations, and we can help your team understand the vital “soft skills” required to successfully partner with cross-functional colleagues in the review process.
Consulting
Medical Affairs, Medical Science Liaisons, and Medical Information
With over 25 years of proven leadership experience across a broad range of medical affairs functions, we have the expertise and experience navigating the needs and structures to support startups, product launches, integrations, divestitures, global expansion, and centralization or decentralization of your medical affairs function. What’s different about us? We have actually done it!
Medical Review
Frustrated by your organization’s medical review process? We can partner with stakeholders in Commercial, Regulatory, Legal and Compliance to identify problematic areas and increase efficiency of the material review process by:
- assessing process effectiveness
- addressing growth opportunities
- implementing process enhancements
- sharing best practices
