Nonclinical
Regulatory Writing
Acumen provides expert nonclinical writing for regulatory submissions in the biopharmaceutical industry. Our team of seasoned medical writers is adept at crafting nonclinical study reports, briefing books for scientific advice meetings, Investigator’s Brochures, and summary modules for INDs, CTAs, NDAs, and BLAs. Acumen’s experienced medical writers partner with your team to power successful submissions.
“Given the breadth and depth of the Acumen team’s technical and scientific expertise, they are a great partner in developing high-quality IND documentation across all modules. Importantly, their team operates as a seamless extension of Sponsor development teams, and they share common goals of accuracy, attention to detail, scientific rigor, and adherence to timelines.”
DELIVERING SUCCESSFUL SUBMISSIONS
Regulatory submissions are complex and demand scientific precision, regulatory expertise, effective project management, and cross-functional collaboration. Sponsors are often challenged with tight timelines and limited resources, hindering their ability to navigate all the required documentation. At Acumen, our nonclinical writing team, led by experienced PhD-level scientists bring a wealth of writing expertise and knowledge to your existing team.
When we partner with your team, our goal is to efficiently create clear, compliant, and compelling documentation. What sets Acumen apart from other organizations is our commitment to forging robust partnerships with our clients. We meet you at any stage of your development journey by providing thoughtful and adaptable writing support when your team needs it most.
Scientists commit to drug discovery. We commit to bringing drug discovery to life.
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Our program managers lead and manage regulatory submissions including INDs, NDAs, and BLAs.
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See how the Acumen Smart Document Solution helps in preparing high quality regulatory submissions
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Our experienced publications team can author manuscripts and other nonclinical publications.
15+
Nonclinical Writers
40+
Successful IND Submissions
60+
Sponsors for Nonclinical Writing
500+
Module 4 Nonclinical Reports
From Drug Discovery to Submission
Compiling nonclinical documentation for a successful submission starts with expertise.
Our team is composed of PhD-level scientists and experienced industry veterans with extensive regulatory writing knowledge across a broad range of therapeutic areas. No matter your unique situation, our team has probably seen it before and can hit the ground running.
Acumen’s writing teams establish long-term relationships with Sponsors and their cross-functional teams that can last throughout the drug development lifecycle.
We offer flexible levels of support to meet the needs of Sponsors of all sizes, from large companies looking to supplement in-house capabilities to strategically focused companies navigating their first drug submission.
Submission-Wide Consistency with Technology and Quality
Always looking to drive efficiency, Acumen regulatory writers leverage Acumen’s Smart Document Solution, a cloud-based software that is designed to seamlessly integrate with Microsoft Word to streamline the preparation of high-quality regulatory documents.
Not sure where to start? All of the INDs Acumen supports are written to align with eCTD standards, and our writers start with in-house templates honed and improved upon over many submissions. Check them out for yourselves.
Ensuring quality is essential. Acumen’s team of QC and editorial specialists are experts at making the final deliverables consistent and error-free, thanks in part to their document-specific checklists and use of electronic style guides (E-style guide), a component of the Smart Document Solution. And, to make it all the more efficient, we can prepare the final documents in PDF format to accelerate submission publishing timelines.