An Integrated Business Model Delivers Value
A lack of insight into the evolving regulatory landscape leads to operational inefficiencies; inabilities to drive true value from data; and the absence of end-to-end accountability for real impact on better products, innovation and patient centricity. Through our integrated business model, we support R&D strategy for increasingly specialized product portfolios.
New Market Conditions Demand New Approaches
Our approach ensures that our customers are regulatory inspection-ready 365 days of the year – with no surprises, dead investments in regulatory gaps or other similar challenges – in a proactive manner. And by building regulatory engagement into companies’ innovation models, we deliver external compliance solutions as a single industry partner. For more insight into the depth of our regulatory services, visit eversanaconsulting.com.
Accelerating Your Speed To Market
Extensive Portfolio of Regulatory Consulting Services
- Regulatory strategy (pharma/biologics/tissue/medical device/combination products)
- Regulatory submission authoring (IND, CTA, NDA, BLA, MAA, etc.)
- Regulatory submission remediation
- Orphan, Fast-Track, Breakthrough and RMAT designation strategy and submissions
- Collaboration with military branches
- FDA meetings, Advisory Committee meetings & EMA meetings
- Regulatory operations – compliant electronic regulatory submissions
- REMS strategy
- Medical writing
- Notified body meetings
- Post-approval product support
- Recalls and corrective actions
- Labeling compliance
- Advertising and promotion
