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Start with the end in mind: regulatory strategy done right the first time

Regulatory

Strategy, experience and tech, tailored to your goal

Global regulatory approval requires coordination, expertise and adaptability. Certara brings them all together for you by designing your regulatory strategy, streamlining document authoring, and supporting your regulatory affairs teams to ensure compliance and approval.

By adding trusted experts, resources and automation, we simplify your product’s path to market and sidestep delays and holds. We help you collaborate across your teams and execute your entire regulatory journey.

How Certara adds regulatory rigor

Start with a regulatory strategy

We recommend a holistic, proactive regulatory strategy tailored to your goals and therapy.

AI enabled regulatory support

Generative AI solutions streamline submissions, enhance accuracy, and ensures compliance.

Proactive risk management

Regulatory services identify and mitigate submission risks early, ensuring smooth submissions.

We start with you

We start with a regulatory plan tailored to you, ranging from regulatory strategy, quality and compliance, risk mitigation, submission support, transparency, and more.

  • We think globally while accounting for local nuances
  • We ask the right questions up front to ensure you achieve your goals, from strategy to submission and beyond

Regulatory services

Strategic guidance and end-to-end support to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through market approval.

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Our regulatory writing services offer expertly crafted, high-quality documents for drug development, ensuring compliance and timely submissions.

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Certara’s Regulatory Submissions Services: Expert guidance for IND, NDA, BLA, and MAA submissions, ensuring quality, efficiency, and compliance for biopharmaceutical companies.

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Our tech-enabled clinical disclosure services ensure global regulatory compliance, supporting clear communication and trust in drug development.

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Certara offers Plain Language Documents to meet EMA/UK regulations with customizable templates, infographics, and accessible designs for clinical trial communication.

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Certara's regulatory operations services optimize processes, ensuring efficiency and compliance throughout the entire submission journey.

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Pharmacovigilance (PV) writing services for seamless drug safety and pharmacovigilance document compliance, leveraging advanced expertise and technology.

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Expertly written patient narratives, enhanced by CoAuthor, ensuring consistency, quality, and improving safety reporting.

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Our medical affairs consulting services ensure compliance, streamline timelines, and reduce internal burdens.

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Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.

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Strategic guidance and end-to-end support to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through market approval.

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Regulatory success with expert guidance

Certara delivers unmatched expertise in navigating complex global regulatory landscapes, enabling faster approvals and ensuring compliance at every step.

40
million pages published in eCTD submissions since 2016
300
global regulatory submissions supported
40
original IND submissions since 2022
20
marketing application submissions since 2022

Regulatory resources

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Announcement

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

Certara’s new survey findings show that 50% of Americans are unaware of FDA and NIH plans to phase out animal testing for certain types of drugs.
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White Paper

Best Practices for Developing High Quality, On Time Submissions

Sponsors often struggle with submission planning. Read this white paper to learn how to develop a plan that minimizes stress and increases your chances of regulatory success.
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On-Demand Webinar

RAPS Sponsored Webcast: Leveraging Today’s Technology to Accelerate Submissions: Real Life Examples and Lessons Learned

As the drug development industry strives to accelerate submission timelines and improve patient access to healthcare solutions, regulatory professionals are increasingly pressured to leverage technology to go faster.
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White Paper

Understanding Europe’s New Clinical Trial Regulations (EU-CTR)

While the new EU-CTR will help to streamline clinical trials, which will benefit both patients and researchers, there are some challenges for Sponsors adjusting to this new regulation.
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On-Demand Webinar

Stay on Track and Get Some Sleep: Marketing Application Best Practices

Without careful execution and the ability to navigate unexpected challenges, marketing application submissions are prone to falling off track and costing valuable time and resources
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“I consider [Certara] to be the gold standard for our vendors because of the excellent service they provide.”

Vice PresidentRegulatory Affairs Banner Life Sciences

Partner with Certara for regulatory success

Collaborate with Certara to streamline your path to regulatory approval. Leverage our expertise, innovative tools, and strategic planning for faster approvals, minimized risks, and global compliance.

Streamlined submissions with expert coordination and AI-driven tools
Holistic strategies ensuring compliance with global and local regulations
Trusted expertise to navigate complex regulatory landscapes

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Explore our solutions across drug development

Discovery solutions

Drive discovery success using Certara’s advanced modeling, data integration, and simulation tools to refine candidates and streamline decision-making.

Preclinical solutions

Harness biosimulation and predictive modeling to streamline preclinical development and increase IND submission success.

Early clinical solutions

Achieve trial success with Certara’s advanced biosimulation and data platforms, accelerating approvals and empowering data-driven clinical insights.

Late clinical solutions

Streamline trial data standardization and validation, regulatory compliance, and submission preparation, ensuring precision, speed, and global confidence.

Commercial and market access solutions

Maximize your therapy’s success with Certara’s advanced analytics and real-world data integration, delivering persuasive value propositions, optimizing pricing, and ensuring payer-ready strategies.

Meet our experts

👁 Kevin Hershberger
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Experts

Kevin Hershberger

Vice President, Certara Drug Development Solutions

25+ years of pharma project leadership and cross-functional program management experience.
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👁 Francesca Scalia, M.S.c, PMP
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Experts

Francesca Scalia, M.S.c, PMP

Senior Project Manager, Certara Drug Development Solutions

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👁 Jo Ann Malatesta
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Experts

Jo Ann Malatesta

Director of Clinical Operations, Certara Drug Development Solutions

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