Certara’s regulatory operations services ensure effective and efficient submissions across global health authorities. With our team of seasoned professionals and advanced GlobalSubmit™ eCTD software, we provide the expertise and tools you need to meet stringent regulatory requirements, avoid submission delays, and maintain global compliance.
Regulatory Operations Services
Optimize your regulatory submission journey
Certara simplifies the complexities of regulatory operations with tailored solutions, cutting-edge eCTD software, and expert guidance.
Learn more about our regulatory operations services
Streamlined regulatory operations for global compliance
Expert guidance
Benefit from decades of experience in regulatory submissions and compliance.
Efficient submissions
Meet deadlines with validated, error-free eCTD submissions.
Global reach
Support for FDA, EMA, MHRA, Swiss Medic, TGA, and Health Canada.
Advanced technology
Utilize GlobalSubmit™ software for streamlined publishing, validation, and review.
Why Certara stands out in regulatory operations
Certara delivers unmatched expertise and innovative solutions, ensuring your regulatory submissions are accurate, compliant, and timely.
Tailored solutions for every submission need
Meet our regulatory operations specialist
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Experts
Evan Richardson
Senior Director, Regulatory Operations and Clinical Disclosure
Evan leads a global team of experts ensuring compliance with clinical trial data disclosure regulations.
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Experts
Maryanne Loscalzo
Associate Director, Regulatory Operations
Over 20 years of experience in eCTD submissions and FDA interactions.
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View allSpeak with a regulatory operations specialist
Certara’s expert team is ready to help streamline your regulatory submission process with custom solutions and advanced eCTD software. Contact us today to discuss how we can meet your unique needs.
Proven track record of successful global submissions.
Expertise in navigating complex regulatory requirements.
Advanced solutions to ensure compliance and efficiency.
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Frequently asked questions
What is an eCTD submission?
The electronic Common Technical Document (eCTD) is a standardized format for regulatory submissions to health authorities globally.
How does Certara assist with regulatory submissions?
Certara provides expert consultation, advanced GlobalSubmit™ software, and full-service support for efficient and compliant submissions.
What agencies does Certara support?
Certara supports global submissions to FDA, EMA, MHRA, Swiss Medic, TGA, and Health Canada.
