## Regulatory products

- Accelerate the creation of regulatory documents with [AI-generated content](https://www.certara.com/coauthor/), freeing up writers for key analysis, messaging, and refinement.
- Publish, validate, and review your eCTD submissions with [GlobalSubmit eCTD Software](https://www.certara.com/globalsubmit-ectd-submission-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](https://www.certara.com/pinnacle-21-enterprise-software/).
- 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](https://www.certara.com/send-explorer-software/).

## Regulatory services

- [Strategic guidance and end-to-end support](https://www.certara.com/services/early-development/regulatory-affairs-consulting/) to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through market approval.
- Our [regulatory writing services](https://www.certara.com/regulatory-science/regulatory-writing/) offer expertly crafted, high-quality documents for drug development, ensuring compliance and timely submissions.
- Certara’s [Regulatory Submissions Services](https://www.certara.com/regulatory-science/regulatory-submissions/): Expert guidance for IND, NDA, BLA, and MAA submissions, ensuring quality, efficiency, and compliance for biopharmaceutical companies.
- Our tech-enabled [clinical disclosure services](https://www.certara.com/regulatory-science/transparency-disclosure/) ensure global regulatory compliance, supporting clear communication and trust in drug development.
- Certara offers [Plain Language Documents](https://www.certara.com/regulatory-science/transparency-disclosure/plain-language-summaries/) to meet EMA/UK regulations with customizable templates, infographics, and accessible designs for clinical trial communication.
- Certara's [regulatory operations services](https://www.certara.com/regulatory-science/regulatory-operations/) optimize processes, ensuring efficiency and compliance throughout the entire submission journey.
- [Pharmacovigilance (PV) writing services](https://www.certara.com/regulatory-science/safety-and-pharmacovigilance/) for seamless drug safety and pharmacovigilance document compliance, leveraging advanced expertise and technology.
- Expertly written [patient narratives](https://www.certara.com/regulatory-science/safety-and-pharmacovigilance/patient-narrative-writing/), enhanced by CoAuthor, ensuring consistency, quality, and improving safety reporting.
- Our [medical affairs consulting services](https://www.certara.com/regulatory-science/medical-affairs-and-scientific-communications-services/) ensure compliance, streamline timelines, and reduce internal burdens.
- Certara’s [regulatory document quality and management services](https://www.certara.com/regulatory-science/document-quality-and-management/) help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.