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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 life cycle to companies in the rare disease, medical device, digital therapies, pharmaceutical, biologic, HCT/P, in IVD, vitamin, food, and cannabis 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 compliant systems, procedures and products.

Regulatory & Regulatory Program Management

Our regulatory solutions are customized to your specific needs.  We can give your staff the information they need to deliver your customized solution or augment your staff (from associate to executive level), to meet your goals/objectives.  The regulatory team includes expert regulatory program managers to track and manage program timelines, critical paths and key milestones, allowing your internal teams to focus on their areas of expertise and facilitate product development.

Regulatory Consulting

  • Regulatory strategy (Pharma/Biologics/Medical Device/Combination products)
  • Orphan, Fast-Track, Breakthrough and RMAT designation strategy and submissions
  • Collaboration with military branches
  • Regulatory submissions
  • Medical writing
  • FDA meetings
  • FDA Advisory Committee meetings
  • EMA meetings
  • Notified body meetings
  • Regulatory operations – Compliant electronic regulatory submissions
  • REMS strategy
  • Post-approval product support
  • Medical safety submissions (pre and post-market)
  • Recalls and corrective actions
  • Labeling compliance
  • Advertising and Promotion
  • RA staff augmentation (associate to executive level)

Regulatory Program Management

Diverse Backgrounds

Our experts leverage their diverse backgrounds to provide the regulatory and quality support needed to help you achieve your goals/objectives throughout the product life cycle. We seamlessly integrate with your team to optimize your regulatory strategy, quality system and operational processes. Our diverse technical background allows us to support companies in numerous therapeutic areas.

  • Integrated Compliance Services

    Our integrated global approach comprises four major services – Pharmacovigilance, Medical Information, Quality Assurance & Quality Systems, and Regulatory – together acting as one partner providing commercial life sciences solutions across the product life cycle.

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  • Regulatory Consulting

    REGULATORY CONSULTING Best-in-class regulatory and quality support at any phase of the product life cycle to companies in the rare disease, medical device, pharmaceutical, biologic, and HCT/P industries.

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