The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration

A Cross-Functional Collaborative Approach to Authoring Disclosure-Ready Submission Documents

Authors: Anaya Rehman, MBBS, MSc; Honz Slipka, MSc; Gunia Kaur, PhD; Michael Pattison, PhD

• Expanding global transparency requirements are reshaping regulatory writing practices.
• Early collaboration supports development of disclosure-ready regulatory submission documents.
• Proactive authoring protects patient privacy, strengthens compliance, and enables efficient public disclosure.

Web of Evidence: Document Dependencies

Authors: Kristen Brotzman, Brenda Taylor, and Steve Sibley

• Global marketing applications require rigorous management of complex document dependencies across the regulatory dossier.
• Effective eCTD submissions depend on structured cross-referencing, hyperlinking, and consistent messaging.
• Overlooking dependencies can create inconsistencies, data gaps, and regulatory review delays.

Strategies and Best Practices for Periodic Aggregate Safety Report Authoring

Authors: Nicholas Churton, Mary Pilkington, and Sarah Threlfell

• Aggregate safety report writing is central to global pharmacovigilance and ongoing benefit-risk evaluation.
• Missed regulatory timelines can lead to warning letters, financial penalties, and reputational risk.
• Disciplined, methodical regulatory writing ensures milestone adherence and inspection readiness.

Efficient Personalization: Mastering Style Guides and Lexicons for Tailored Submissions

Author: Sarah Steffin

• Clean source documents enable efficient automated review and improve document quality.
• Strategic use of style guides and lexicons drives consistency across regulatory submissions.
• Thoughtful application of technology enhances efficiency and strengthens submission readiness.

Rolling NDA and BLA Submissions: Accelerating Regulatory Review

Author: Janet Shoshitaishvili

• FDA agreement and a clearly defined rolling submission plan are critical to NDA and BLA success.
• Strong logistics management and cross-functional coordination maintain timeline adherence.
• Proactive planning and timely responses to FDA Information Requests support regulatory efficiency.

Navigating Regulatory Submissions: Avoiding Common Mistakes

Author: Rachel Bombara

• Avoiding common submission errors is essential for an efficient health authority review.
• Accurate data presentation and early issue identification reduce regulatory risk.
• eCTD templates, validation tools, and structured review checklists improve submission quality.

From Algorithms to Accountability: The Human Core of AI-Driven Medical Writing

Author: Reema Salvaraju

• AI is reshaping regulatory science within frameworks that prioritize transparency and human oversight.
• Human and AI collaboration enhances efficiency and accelerates insight across regulatory workflows.
• Medical writers remain essential to safeguarding scientific accuracy, ethics, and patient safety.

Setting the Pace: Writing an Effective Module 2.4 Nonclinical Overview

Authors: Brenda Taylor and Kelly Smith

• Develop Module 2.4 after Module 2.6 is mature to ensure consistency and aligned messaging.
• Follow the CTD structure and applicable regulatory guidance, tailoring detail to the submission type.
• Maintain traceability through cross-referencing while clearly articulating key product messages.

EDD DPS: Expertise-Driven Document Planning and Support

Author: the Certara Team

• Begin in early development with the end in mind, aligning document strategy with long-term regulatory goals.
• Match experienced regulatory writers to the right documents at the right time.
• Apply strategic planning to enhance scalability, strengthen submission readiness, and minimize rework.

The Evolution of FDA Assessment Aids

Authors: Karen Randolph

• The FDA Oncology Center of Excellence Assessment Aid facilitates NDA and BLA oncology reviews.
• Since 2018, more than 200 oncology approvals have included an Assessment Aid.
• Assessment Aids support streamlined submissions, including RTOR and Priority Review pathways.

ICH M15: Aligning MIDD with Regulatory Expectations

Author: the Certara Team

• Finalization of ICH M15 establishes Model-Informed Drug Development as a harmonized regulatory expectation.
• The guideline defines principles for planning, documenting, and submitting MIDD evidence.
• Multidisciplinary integration and transparent justification strengthen regulatory dialogue and decision making.

Software that accelerates Regulatory Writing and Regulatory Global Submissions

Certara’s software supports high-quality regulatory submissions and accelerates global approvals.

• CoAuthor™ enhances AI-assisted regulatory writing and structured content development.
• GlobalSubmit™ simplifies eCTD publishing and global submission management.
• Pinnacle 21® strengthens submission planning, tracking, and regulatory operations.

Bringing together expertise and technology to strengthen global regulatory submissions, reduce risk, and accelerate patient access worldwide.