NvertBio

Servicing Pharma, medical device and CLIA in these key areas: Vendor selection lifecycle • Request for information (RFI) • Request for proposal (RFP) • Technical/Quality audits Study management oversight • Bioanalytical services • Large molecule technical oversight and scientific advisory • Alignment of technical requirements with feasible timelines Central Lab Coordination • Data Transfer Agreement (DTA) • Sample management and requisition • Preparation and review of CDA, MSA, SOW • Negotiation of budgets, scope refinement, alignment of contractual terms with regulatory expectations • Critical process improvements • Risk assessments and FEMA • Project management