PharmaLex’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle. We employ proven methodologies and hands-on support to optimize
and customize quality and regulatory solutions which are delivered on time, in budget and with the highest quality.
The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team are available to provide support as required.
Limited internal resources and minimal experience with RIM implementation projects
- US-headquartered biopharmaceutical company with European affiliate
- First NDA approved; further, NDAs planned
- Fast-growing company with increasing Regulatory needs
- Limited resources for project management and operational work during configuration and implement phase
- Minimal experience with RIM implementation projects and no experience with Veeva Vault
VigiScreen is a cloud-based software solution that processes incoming ICSRs, automating the analysis of company vs non-company cases, reducing screening workload by up to 80%. A GxP validated system according to GAMP 5 guidelines, CFR Title 21 Part 11 compliant.
PharmaLex offers regulatory compliance services that address the new FDA requirements that have been implemented to govern the tobacco and vape industry.