Streamlining dossier preparation

Medical writing professionals play a pivotal role in preparing regulatory submission dossiers.

They are responsible for clearly, conclusively, and impartially communicating an asset’s safety, efficacy, and suitability to health authorities. Their leadership and expertise are essential in coordinating resources, maintaining timelines, ensuring compliance with guidelines, and upholding quality standards.

This whitepaper shares best practices on how to organise the cross-functional team, develop the project plan, and manage the review process. It highlights the importance of thorough preparation, clear expectation-setting, resolving conflicting feedback, and maintaining quality control. The objective is to equip medical writing teams with a structured, strategic approach that enhances efficiency and fosters confidence in their work.

• Assemble a multidisciplinary team to create, review, and approve extensive dossiers
• Develop a detailed plan that maps out the entire project 
• Set expectations for the many reviewers who will weigh in on the content 
• Manage the review process and resolve conflicting viewpoints 
• Track, document, and implement edits
• Ensure the final submission meets the highest quality standards