Nonclinical Writing for Regulatory Submissions
Comprehensive medical writing support for all nonclinical documentation by our team of experienced scientific writers. From preparation of nonclinical study reports to scientific advice meetings to IND and NDA summary modules, Acumen’s expert 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 multifaceted projects that require scientific excellence, regulatory expertise, program management, and cross-functional collaboration. Sponsors are often operating under tight business timelines and lack the resources and time needed to efficiently navigate all the required documentation. At Acumen, our nonclinical medical writers are experienced scientists that understand the time and effort it takes to shepherd a drug from the lab to the clinic, and we believe that every drug candidate deserves to be presented with documentation that accurately and effectively represents its strengths to regulatory authorities.
Our expert team of nonclinical medical writers bring each drug development story to life by working closely with Sponsor teams to create compelling documentation.
Scientists commit to drug discovery. We commit to bringing drug discovery to life.
-
Our program managers lead and manage regulatory submissions including INDs, NDAs, and BLAs.
-
See how the Acumen Smart Document Solution helps in preparing high quality regulatory submissions
-
See how our experienced publications team can author Manuscripts, and other nonclinical publications.
40+
Successful IND Submissions
500+
Nonclinical M4 Study Reports
50+
De Novo Investigator’s Brochures
Bringing Drug Discovery to Life
Acumen understands how critical it is to deliver clear and concise information on drug activity and safety to global regulatory authorities. Our medical writers partner with Sponsor SMEs and cross-functional teams to efficiently provide persuasive documentation that highlights the potential of every drug. In addition, Acumen’s team of project managers, QC editors, and pre-publishing specialists ensures timely document delivery at the highest standard of quality.
Our team is comprised of PhD-level scientists and experienced industry veteran’s with expertise across therapeutic areas in all phases of preclinical development
Acumen medical writers establish long-term relationships with Sponsors that last throughout the drug candidate lifecycle and in many cases, across multiple drug development programs
We offer flexible writing support for Sponsors of all sizes, from large companies looking to supplement in-house capabilities to strategically focused writing for clients navigating their first drug submission
Submission-wide Consistency with Technology
Acumen’s Smart Document Solution, a cloud-based software that seamlessly integrates with Microsoft Word, is designed to address the key challenges of preparing high-quality regulatory documents for the pharmaceutical industry.
Choose from one of our eCTD-compliant templates
Our dedicated team of QC and editorial specialists use a shortcut ribbon for implementing styles and perform 100% line-by-line QC to data sources following document-specific checklists and client specific style guides (E-style guide) to ensure consistent formatting and style across the entire submission
Our Stylus Toolbar is state-of-the art software that helps standardize styles and operations for consistent document formatting
AcuCite, our reference manager software, easily integrates references into any document