Allison Scott, RAC, has more than a decade of experience as a consultant providing regulatory and quality, investigation, litigation, and compliance support to U.S. and global healthcare and life sciences companies.
Allison is an associate director in the Life Sciences practice at Guidehouse, where clients regularly leverage her expertise across the product lifecycle, from determining Regulatory strategy and securing initial U.S. Food and Drug Administration (“FDA”) approval to addressing post-market issues which may arise.
Allison has obtained U.S. regulatory clearances and approvals and Canadian licensing for international and domestic firms for a wide range of products, including medical software, diagnostic monitoring and imaging equipment, and active therapeutic devices and orthopaedic implants. Allison also has secured humanitarian use device (“HUD”) certifications, humanitarian device exemptions (“HDEs”), and investigational device exemptions (“IDEs”) for multiple products in the U.S. and Canada. In the post-market space, she has provided support to companies needing assistance with compliance issues related to Unique Device Identification (“UDI”), Recalls, Adverse Events, Medical Device Reporting (“MDR”), and Complaint Handling.
Allison uses her diverse regulatory and compliance background combined with strong project management skills to support life science companies with litigation and investigation services. She has supported regulatory, quality system, and compliance diligence audits and reviews for several M&A deals involving medical device firms, including a pre-deal regulatory assessment for a Fortune 20 corporation seeking to expand into market sectors with substantially higher risk profiles. Additionally, she has supported testifying expert witnesses with project management, document review, research, and report writing.
Allison's compliance experience includes assisting various pharmaceutical and medical device companies in the review of their compliance programs, including Sunshine Act-related distributor interviews and transaction reviews, audits of distributor and sales representative spending and reporting, and commercial and medical field force monitoring.