Meet your competitive advantage: Certara’s Clinical Pharmacology Regulatory Strategy Team of Experts
Clinical Pharmacology development programs can be complex. Navigating what your clinical development program needs and when, and how to leverage model-informed drug development (MIDD) ‘responsibly’ can be tricky. The solution your program relies on for success is experience.
At Certara our combined decades of experience covers thousands of INDs and marketing applications. We have experts in 5+ global regulatory regions, providing local support to seamlessly advance global clinical development programs. We can tap into Certara’s large, global resource base of 46+ clinical pharmacologists with deep subject-specific expertise in a wide range of areas. We keep a constant finger on the pulse of global regulatory activity, precedent making decisions, new guidance and ‘trends’ in a constantly evolving landscape. We can leverage precedent cases and know-how of recent developments to engage with health authorities regarding complex situations and new approaches.
This team has the reviewer mindset that helps you to look beyond regulatory guidance. We use our reviewer experience to either help you put your best foot forward going into regulatory interactions or to prepare for regulatory feedback by anticipating it. This approach will help you save time and maximize your clinical development investment.
How we can support your regulatory journey
- Gap Analyses
- What issues could delay your product development and how to fix them
- How to leverage model-informed approaches responsibly
- Regulatory Meeting Support
- What questions to ask and when
- Meeting package strategy, review or writing
- Meeting preparation and response strategy
- Attendance and post-meeting support
- Global Bridging strategy
- Multi-regional requirements and regulatory pathways
- Inter-regional extrapolation
- NDA/BLA pre- and post-submission support
- Modules 2.7.1, 2.7.2, ISI: content organization and strategy, writing or strategic review.
- Application Orientation meetings and other time-clock meetings (i.e., midcycle)
- Information Requests, Day 120/150/180 assessments: anticipate potential concerns and support responses to health authorities
- Labeling and labeling negotiations: Getting the most out of your CPDP and modeling to avoid post-marketing commitments
- PMR/PMC negotiations
- SMEs for Mock Advisory Committee and Ad-Boards
- Stalled Development Support
- Clinical holds
- CRL’s
- Other support
- Acceptance of Model Informed Drug Development (MIDD) approaches
- Due Diligence support
- Pediatric Drug Development strategy support
- Regulatory strategy-related clinical pharmacology project-level support
Results that speak volumes
90 percent of new drug approvals by the U.S. Food and Drug administration (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022. The is the 9th consecutive year that Certara’s customers who use the Companies biosimulation software and technology-driven services have had novel drugs approved by the FDA in a wide range of therapeutic indications from oncology to rare diseases.
