Certara’s regulatory science services empower you to write a better submission, navigate global regulations, and achieve timely approvals. From early stage strategy to post marketing compliance, we ensure your pathway to market is efficient and compliant in any phase.
Regulatory Services and Medical Communications
Transform complexity to clarity
The support you need for regulatory approval
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expert project managers, regulatory writers, editors, and publishers
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top biopharma companies partner with us to accelerate drug development timelines
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Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024.
Our regulatory writing services offer expertly crafted, high-quality documents for drug development, ensuring compliance and timely submissions.
Certara’s Regulatory Submissions Services: Expert guidance for IND, NDA, BLA, and MAA submissions, ensuring quality, efficiency, and compliance for biopharmaceutical
Our tech-enabled clinical disclosure services ensure global regulatory compliance, supporting clear communication and trust in drug development.
Certara offers Plain Language Documents to meet EMA/UK regulations with customizable templates, infographics, and accessible designs for clinical trial communication.
Certara's regulatory operations services optimize processes, ensuring efficiency and compliance throughout the entire submission journey.
Pharmacovigilance (PV) writing services for seamless drug safety and pharmacovigilance document compliance, leveraging advanced expertise and technology.
Expertly written patient narratives, enhanced by CoAuthor, ensuring consistency, quality, and improving safety reporting.
Our medical affairs consulting services ensure compliance, streamline timelines, and reduce internal burdens.
Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.
Regulatory touches every phase of your drug
Regulatory discipline is key to every successful submission. And a clear regulatory strategy can contribute to a robust structure to orchestrate your drug’s development. We can help you build a logical flow through each phase to speed your drug to success globally.
Regulatory resources
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Streamline your path to approval with Certara’s expert support. Contact us today to discuss how we can accelerate your drug’s market entry.
Rapid turnaround to meet critical submission deadlines
Consultation on developing a structured approach to regulatory affairs
Building a strong narrative for your submission
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Regulatory case studies
CMC writing support lifts clinical hold
The client had a clinical hold for almost 2 years, and they only had 1.5 months to resubmit these documents to the FDA.
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Supporting a rolling BLA submission under tight timelines
A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second submission we supported for this Sponsor in the overall partnership.
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Complex patient profile and narrative
A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative templates for one of its most complex studies.
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