CTD Module 2 Summaries
Regulatory-focused summaries that communicate your programme effectively.
CTD Module 2 Summaries are critical to the success of your regulatory submissions delivering high-level, strategic overviews of clinical data to global health authorities. At QInscribe, we specialise in authoring regulatory-compliant, clearly structured CTD Module 2 documents that support efficient regulatory review.
Our capabilities include Clinical Overview (Module 2.5), an integrated analysis of the clinical development program and benefit-risk profile, as well as Clinical Summary Module 2.7, comprising of 2.7.1 to 2.7.4.
With extensive experience across therapeutic areas and global submission requirements, our expert regulatory writers know how to emphasise the most critical elements of your clinical program. We ensure your Module 2 Summaries are strategically written, submission-ready, and designed to minimise regulatory questions and avoid delays.
Harness Our Expertise
Discover our expert support for authoring clear, compliant CTD Module 2 documents that align with global regulatory expectations and highlight the value of your clinical programme.
- Writing Module 2.5 Clinical Overview
Clear, expert analysis highlighting the strengths and strategic relevance of your clinical data, ensuring a compelling narrative aligned with regulatory expectations. - Writing Module 2.7 Clinical Summary
Comprehensive yet concise summaries of clinical efficacy, safety, pharmacokinetics, pharmacodynamics, and biopharmaceutics data, structured according to global regulatory requirements. - Regulatory Guidance & Expertise
Detailed understanding and adherence to international submission formats (eCTD), global regulatory guidelines, and industry best practices. - Integration & Consistency
Seamless integration and consistency across Modules 2.5, 2.7, and supporting Module 5 clinical data to ensure coherence, clarity, and regulatory compliance throughout the submission. - Quality Control & Review
Robust standalone QC processes and scientific peer review ensure that all Module 2 summaries are accurate, consistent, and fully aligned with regulatory requirements. Every document undergoes meticulous review for data integrity, clarity, and compliance, ensuring submission-ready quality and minimizing the risk of regulatory queries.
What You Gain by Partnering with QInscribe
Confidence in Regulatory Submissions
Expertly crafted documentation adheres strictly to global regulatory standards, reducing risks associated with inaccuracies or misinterpretations.
Faster Turnaround Without Compromise
Concise, compliant Module 2 documents facilitate quicker review and approval by global health authorities (FDA, EMA, MHRA, PMDA etc).
Less Administrative Burden
Clearly summarised data reduces ambiguity, minimising potential regulatory questions or approval delays.
Clear, Persuasive Communication
Clearly articulated summaries position your clinical data effectively, optimising the impact of your submission.
A Scalable Solution
Support one document or an entire portfolio, our services flex around your needs and timelines.
Let’s simplify your path to submission.
Talk to us about your upcoming CTD Module 2 Summaries needs and how we can reduce pressure on your internal team, while keeping your trial timelines on track.