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.
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!
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.
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.
SEND Explorer®
SEND Explorer는 비임상 연구 데이터에 대한 고급 보기, 데이터 요약 및 시각화 기능을 제공하기 위해 과학자들이 설계한 검증된 웹 기반 애플리케이션입니다. 또한 이 소프트웨어를 사용하면 과학자들이 내부 의사 결정을 위해 연구 데이터 및 관련 시각화에 쉽게 액세스할 수 있도록 하여 회사가 규제 제출을 위한 SEND 데이터 세트를 만드는 데 투자를 최대한 활용할 수 있습니다.
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.
Pinnacle 21 Enterprise CDISC software checks whether your data comply with CDISC standards, controlled terminology, and dictionaries like MedDRA and WHODrug. 이 과정은 미국 FDA, 일본 PMDA, 중국 NMPA와 같은 규제기관에 데이터 제출 전 완결성을 확인하기 위한 점검입니다. 각 기관의 Business Rule을 준수하는지 확인하여 사전에 문제를 파악하고 Fix tip(문제해결 팁)을 통해 원활한 진행과 통찰력을 제공합니다.
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.
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.
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.
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.
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.
