Regulatory Consulting

What You Need, When You Need It

EVERSANA has a proven track record of providing best-in-class regulatory and quality support at any phase of the product lifecycle to companies in the rare disease, medical device, pharmaceutical, biologic, and HCT/P industries. We help clients navigate the ever-changing global regulatory and quality landscape and deliver customized solutions and strategic guidance to expedite approvals, increase speed to market, and maintain or regain compliance.

EVERSANA has a bias for action, not simply advice. Whether it’s short-term assistance or a long-term relationship, we will partner with you to facilitate patient access to your novel products and therapies while positioning you for maintaining complaint systems, procedures and products.

Learn more about our Regulatory & Compliance Consulting Solutions by visiting www.eversanaconsulting.com.

Sample Services

  • Regulatory Strategy & Compliance
    • Regulatory Strategy, Submissions & Meetings Consulting
    • Due Diligence & GAP Assessments
    • Breakthrough, Fast-Track, Orphan/Rare Strategy & Submissions
    • Post-Approval Regulatory Support
    • REMS
    • FDA Mock Audits
    • Regulatory Training
  • Regulatory Operations & Submissions
    • Submissions Planning & Management
    • 21 CFR Part 11 eSubmissions
    • eGateway management
  • Quality Assurance, Control & Hosted Quality System Solutions
    • Process & Resource Assessments
    • Quality Remediation
    • Policy, SOP & Batch Record Review, Preparation & Optimization
    • Quality System (QS) Development, Assessment & Optimization
    • CAPA Planning & Execution
    • Training – FDA, EU, GxP, QSR & Design Control, Validation
    • QA/QC/QE Staff Augmentation
    • Supplier & Internal Audit Programs
    • QMS/DMS/TMS Implementation & Operation
    • Hosted eQMS Solution

Find out how we can take your business to the next level.