Regulatory products

• Accelerate the creation of regulatory documents with AI-generated content, freeing up writers for key analysis, messaging, and refinement.
• Publish, validate, and review your eCTD submissions with GlobalSubmit eCTD Software, eliminating risk and expediting regulatory acceptances.
• Increase the speed and quality of your clinical trial submission data with the Pinnacle 21® Clinical Data Management & Automation Suite.
• A validated, web-based application to provide advanced viewing, data summarization, and visualization capabilities for study non-clinical data produced in SEND format with SEND Explorer.

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.
• 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 companies.
• 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.