Non-Clinical Regulatory Writing
I provide expert nonclinical writing for regulatory submissions in the biopharmaceutical industry & beyond. I am adept at writing nonclinical study reports, briefing books for scientific advice meetings, Investigator’s Brochures, and summary modules for INDs, CTAs, NDAs, and BLAs. I can work independently or in a team to deliver the highest quality, fastest results.
Working with Peter on our IND documentation was an exceptional experience. His unparalleled breadth and depth of technical and scientific expertise were evident across every module, making him an invaluable partner in developing truly high-quality submissions. He's exactly the medical writer you want on your critical projects.
- Rudi Goldenblum, MS, Vice President
Success, The First Time
Regulatory submissions are inherently complex, demanding scientific precision, deep regulatory expertise, robust project management, and seamless cross-functional collaboration. I understand that sponsors frequently grapple with tight timelines and limited resources, which can hinder their ability to navigate all the required documentation. As a physician medical writer, I bring not just a wealth of writing expertise, but also a unique clinical insight and practical understanding directly to your existing team.
When I partner with you, my unwavering goal is to efficiently create clear, compliant, and compelling documentation. What sets Takacs Medical Writing apart is my personal commitment to forging robust, trust-based partnerships with my clients. I'm ready to meet you at any stage of your development journey, providing thoughtful and adaptable medical writing support precisely when your team needs it most.
Scientists commit to drug discovery. I commit to bringing drug discovery to life.
I have extensive experience with publications, and I can help author manuscripts and other nonclinical publications.
I am able to help manage regulatory submissions including INDs, NDAs, and BLAs.
I have extensive experience with all Microsoft Suite Products, Adobe Photoshop, Acrobat, and Veeva Cloud Based Software.
From Research to Submission
Compiling nonclinical documentation for a successful submission is all about specialized expertise. As a physician medical writer, I bring extensive regulatory writing knowledge across diverse therapeutic areas. This background allows me to quickly understand your unique situation and contribute effectively from day one.
I'm committed to building strong, long-term relationships with Sponsors and their cross-functional teams, providing flexible levels of support—from augmenting large in-house teams to guiding smaller companies through their initial drug submissions.
Expert Collaboration
Collaboration is at the heart of how I approach not only non-clinical writing, but all writing. I work seamlessly within teams to offer a wide spectrum of services.
Some of my expertise includes:
-
Project Management: Carefully deploying necessary resources and managing complex timelines with others
-
Quality Control and Editorial: Ensuring the final document delivery is the highest possible quality
-
Document Pre-publishing: Aligning the final product with expected submission standards
-
Medical Review: Consulting on the medical and scientific accuracy and appropriateness of data and study design
-
Other writers/specialists to optimize project efficiency
-
Publications and Medical Affairs
-
Graphic Planning & Design
-
Clinical Trial Disclosure and Redaction
Deeper Knowledge
Medical writers play a crucial role, from breaking down complex scientific research for regulatory agencies to helping biopharma and health companies engage their audiences. As a physician, I offer a unique clinical perspective, ensuring your content not only meets these standards but also deeply understands and reflects the realities of patient care and medical practice.
Faster Time-To-Write
While no one possesses universal knowledge, medical writers - especially physician writers - excel at rapidly assimilating new therapeutic areas, complex concepts, and specialized terminology. In the fast-paced biopharmaceutical and medical device industries, this agility is invaluable, empowering companies to remain at the forefront of innovation.
Multiple Skillsets
Beyond core scientific knowledge, writing proficiency, and project management, a highly effective medical writer often possesses a unique skill that enhances outcomes—be it biostatistics expertise or specialized publication management. For your projects, I add to this foundation with my unique physician's perspective, proven statistical analysis acumen, and a strategic understanding of digital content, copywriting, and SEO to maximize your impact.