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Certara has developed leading technologies that save time and resources during the process of preparing for and executing regulatory submissions and submission process. The result: getting therapeutics and medical devices to market faster. According to analysis by the Tufts Center for the Study of Drug Development, the average cost to develop and gain marketing approval for a new drug is $2.55 billion. A quarter of this cost is in creating content and meeting regulatory requirements. How can drug developers accelerate this process and maximize their investment? Regulatory submissions are a core foundation to Certara. Our suite of software tools support data compliance, streamlined medical writing, and the ability to efficiently publish, validate, and review your eCTD submissions.

Ensure submission readiness

Maximize chances of submission approval

Certara’s Pinnacle 21 Enterprise Software helps you effortlessly prepare compliant, high quality clinical trial data for regulatory submission. Our regulatory solutions help you review a submission’s data quality, CDISC compliance, and fitness for use, in one cloud platform – the same platform used by the FDA and Japan’s PMDA! That’s why we’re trusted by 24/25 leading pharmas, 22/25 largest biopharmas, and 11/15 top CROs!

Ensure submission readiness
Manage eCTD submissions

Simplify complex regulatory processes.

With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients.

Manage eCTD submissions
Increases writing efficiency

Free your medical writers from mundane tasks.

Revolutionize the work of your writing teams with CoAuthor. Certara’s software is a purpose-built writing tool designed by writers for writers that encompasses organization, collaboration, and automation to generate your regulatory documents. Unlike traditional word processing software to write reports, this cloud-hosted and validated regulatory software allows you to measurably streamline your processes.

Increases writing efficiency
Learn more about SEND Explorer

SEND Explorer®

SEND Explorer is a validated, web-based application designed by scientists to provide advanced viewing, data summarization, and visualization capabilities for nonclinical study data. The software also allows companies to make the most of their investment in creating SEND datasets for regulatory submissions by making study data and associated visualizations easily accessible to scientists for internal decision-making.

Learn more about SEND Explorer

Case Study: Prelude Therpeutics

In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management software for their electronic common technical document (eCTD) submissions. The regulatory team at Prelude Therapeutics is very lean and responsible for more than 30 submissions annually; therefore, the utmost efficiency in publishing, checking the validation criteria, and reviewing eCTDs is required.

View the case study
Case Study: Prelude Therpeutics
What is your data fitness score?
What is your data fitness score?

Pinnacle 21 Enterprise CDISC software checks whether your data comply with CDISC standards, controlled terminology, and dictionaries like MedDRA and WHODrug.  This is your final checkpoint before datasets embark for the FDA, PMDA, or China’s NMPA. It checks whether your data adhere to each agency’s business rules. Issues may derail their standardized review tools, so we offer insights and “Fix Tips” so that you stay on track. 

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Medical writing software that increases drug development efficiency

Revolutionize the work of your writing teams with Synchrogenix™ Writer. Certara’s software is a purpose-built writing tool designed by writers for writers that encompasses organization, collaboration, and automation to generate your regulatory documents. Unlike traditional word processing software to write reports, this cloud-hosted and validated regulatory software allows you to measurably streamline your processes.

Request a demo
Medical writing software that increases drug development efficiency
Trevor Standish
Trevor Standish Product Director

Trevor Standish is a Product Director with over ten years of experience in creating and implementing innovative software products across various industries, including pharmaceuticals, finance, and marketing. He is a customer-focused team leader with expertise in various areas such as product SDLC management, UI/UX design, AI/ML systems, and innovation.

Trevor has extensive experience in managing software development life cycles, defining global product strategy and roadmaps, and leading teams in the transition to Agile methodologies. He has presented at various industry conferences, assisted global sales teams, and presented at executive roundtables.

He has held positions at Certara, Concentric, Synchrogenix, and Fifth Third Bank Corp., where he demonstrated strong leadership skills, managed product portfolios, and defined strategic product roadmaps.

Certara Erin E
Erin Erginer Director of Product

Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Accomplished, analytical director possessing strong interpersonal and communication skills with experience in managing multi-functional teams at both a strategic and tactical level. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations. Built and introduced countless strategies within R&D to achieve efficiencies and resolve process and application gaps. Experienced in operations oversight and guidance, including resource and financial projections and prioritization.