Biotech and pharma teams face mounting pressure to deliver high-quality documents that meet regulatory standards, accelerate timelines, and minimize costly rework. Yet, many organizations still treat Quality Control (QC) as a final checkpoint, missing opportunities to embed quality throughout the writing process. This can lead to inefficiencies, repeated reviews, and increased risk of errors.
By adopting a QC‑mindset cross-functionally from the outset with collaboration between authors and QC specialists, teams can streamline document development, reduce costs and turnaround times, and produce documents of enhanced quality and compliance. Proactive strategies such as standardized authoring, robust QC planning, and effective communication help minimise unnecessary effort and allow QC specialists to focus on content accuracy.
In this webinar, MMS experts will share practical insights and real-world examples on how to “write with QC in mind.” Presenters Bhavya ChandreGowda (Associate Manager, Quality Control), Sharon Oyetunde (Manager, Regulatory & Medical Writing), Emily Scott (Senior Medical Writer), and Katrina O’Connor (Senior Medical Writer) will discuss:
- Building QC-focused writing strategies for process, authoring, communication, and tools
- Techniques for achieving first-time quality and reducing rework
- Best practices for QC checklists, document storage, and collaboration
- How these QC principles apply not just to medical writing, but across all functions in the pharma industry
Join us to discover how embedding QC from the start can transform your document development process delivering higher quality, greater efficiency, and stronger regulatory outcomes.
- Discover how embedding QC from the start can transform document development and improve compliance
- Gain practical strategies for building QC-focused writing processes, communication, and tools
- Learn techniques to achieve first-time quality and minimise costly rework
- Explore best practices for QC checklists, document storage, and collaboration
- Understand how QC principles apply across medical writing and broader pharma functions
- How a QC-focused writing strategy can reduce rework, improve document quality, and accelerate regulatory timelines.
- How standardized authoring tools and automated processes streamline collaboration between document authors and QC specialists,.
- How proactive planning and clear communication can minimise errors and ensure compliance from draft to submission.
- How cross-functional approaches to QC drive efficiency and consistency across clinical development documents.
- What practical steps you can take to embed QC principles throughout your document development workflow.
- Authors across all functions including medical writing, regulatory, transparency, data management, pharmacovigilance, and statistics, and quality control specialists seeking to improve document accuracy and efficiency.
- Regulatory affairs professionals aiming to streamline submissions and ensure compliance.
- Clinical development teams looking to reduce rework and accelerate timelines.
- Project managers and team leads interested in cross-functional collaboration and best practices.
- Anyone involved in authoring, reviewing, or managing clinical and regulatory documents who wants to embed quality from the start.
- Who is this webinar for?
This webinar and panel discussion is designed for biotech and pharmaceutical leaders, clinical development professionals, medical writers, quality control specialists, and regulatory decision-makers seeking actionable strategies to optimise document quality and streamline regulatory submissions. Whether you are involved in authoring, reviewing, or managing clinical and regulatory documents, this session will provide insights into embedding QC principles, improving collaboration, and enhancing efficiency across teams.
- Will there be a recording available?
Yes, a recording will be provided to all registered attendees following the scheduled event.
- Where can I get more information on the content presented?
To connect with the presenters, email info@mmsholdings.com and our team will connect you with the right person.
Register Now
Suggested For You
webinar
June 26th, 2025
De-Risking Development with Specialized Data Strategies: From Trial Design to Submission
webinar
October 21st, 2025
A Practical Guide to Expedited Regulatory Pathways
webinar
September 25th, 2025
The Psychedelic Inflection Point: What Sponsors Need to Know Now
webinar
August 28th, 2025
Shaping the Future of AI-Enabled Medical Writing
webinar
July 31st, 2025
Design, Data, and Decisions in Oncology Trials
webinar
April 30th, 2025
Advancing Clinical Development with Innovative Trial Design and Regulatory Strategies
webinar
March 25th, 2025
Overcoming NDA/BLA Submission Challenges: Practical Strategies for Success
webinar
October 22nd, 2024
Optimal Strategies to Protect Commercially Confidential Information (CCI) in Clinical Documents and Report Trial Results Under Revised EU-CTIS Transparency Rules
webinar
September 26th, 2024
Regulatory Pathways for Nonprescription Drugs: A Deep Dive into OTC Monograph Reform and FDA Guidance
webinar
September 12th, 2024
No Stone Unturned: Optimizing the Use of Expedited Pathways and Oncology Center of Excellence Programs to Optimize Drug Development in Oncology
webinar
July 11th, 2024
The Rising Burden of Pharmacovigilance (PV) Requirements in Early Drug Development
webinar
June 26th, 2024
A Psychedelic Shift: Assessing the Potential for Nonmedical Use in a Changing Regulatory Landscape