Certara’s clinical pharmacology consultants help you make informed decisions at every stage of your drug development process. Our services include gap analyses, due diligence, regulatory meeting preparation, NDA/BLA/MAA submission support and global bridging strategies—all designed to address potential challenges and accelerate progress.
Clinical Pharmacology Regulatory Strategy
Optimizing clinical development with regulatory expertise
Improve clinical programs, mitigate risks, and accelerate approvals with our expert team in model-informed drug development and regulatory science.
Tap into Certara’s expertise
Expert insights, streamlined solutions
グローバル規制に関する専門知識
Certara’s experts include former regulators from major global agencies, who provide local insights across all key regulatory regions.
Precedent-driven strategies
We leverage real-world cases and recent regulatory developments to guide your program.
Reviewer mindset
Our team of former clinical pharmacology assessors can prepare you for successful regulatory interactions.
スムーズな連携
We provide end-to-end support, from MIDD approaches to labeling negotiations.
Bridging science and strategy for success
Certara’s unique approach combines scientific innovation with regulatory foresight.
From pediatric drug development strategies to addressing stalled development issues, our team ensures your project progresses smoothly.
A suite of tailored services
薬事関連コンサルティング
利用可能なデータを最大限に活用し、規制当局の承認を得るまでの時間を短縮することで、成功の確実性を高めます。
Clinical pharmacology experts
Specialized support for complex programs.
モデルに基づく医薬品開発
Innovative strategies to optimize outcomes.
小児用医薬品開発
Transform pediatric drug development with innovative modeling, simulation, and regulatory strategies.
メディカルライティング
Discover a wide range of tailored medical and regulatory writing capabilities that cover the full drug development spectrum.
Partner with industry leaders
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エキスパート
Eva Berglund, PhD
Senior Director, Clinical Pharmacology and Regulatory Strategy, Certara Drug Development Solutions
Dr. Berglund has over 12 years of experience working with all types of molecules in marketing applications, clinical trials and scientific advice procedures in the EMA Network of National agencies.
専門家に相談する
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エキスパート
Krithika Shetty, PhD
Director, Clinical Pharmacology, Certara Drug Development Solutions
Dr. Shetty provides strategic regulatory clinical pharmacology support to client programs including navigating the requirements of Project Optimus, development program evaluation, due diligence subject matter expertise among others.
専門家に相談する
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エキスパート
Justin Hay, PhD
Senior Director, Certara Drug Development Solutions
Dr. Hay has over 25 years of clinical pharmacology experience, previously working as a clinical pharmacology assessor for the MHRA (UK) and EMA.
専門家に相談するExpand your knowledge
全て見るTake the next step with Certara
Connect with our team to discuss how Certara’s Clinical Pharmacology Regulatory Strategy can optimize your drug development program. We’re here to provide expert guidance tailored to your unique challenges.
Why contact Certara?
Proven track record in regulatory success.
Innovative strategies that maximize value.
Comprehensive support across global regions.
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Explore our broader capabilities
よくある質問
What is clinical pharmacology regulatory strategy?
It is a specialized approach to optimize your drug’s clinical development pathway while ensuring regulatory compliance.
How does Certara support global submissions?
Our team provides local and global expertise, addressing multi-regional requirements seamlessly.
What is MIDD, and how does it benefit my program?
Model-Informed Drug Development leverages predictive models to improve decision-making and efficiency.
