Clinical Regulatory Writing
Distinguished by my extensive experience and an unwavering commitment to scientific integrity, Takacs Medical Writing delivers the highest quality clinical regulatory documents. I provide leading writing services, from protocols and clinical study reports to briefing documents and comprehensive NDA/BLA submissions.
Peter quickly became an invaluable extension of our team, providing comprehensive writing and strategic planning support. He consistently met our demanding timelines, demonstrating remarkable patience and agility when strategic direction shifted rapidly. His high-quality documents were instrumental in our successful accelerated BLA and subsequent full approval.
- Mark Vasquez, Clinical Affairs
Supporting All Your Documents
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NDA and BLA Submissions: All clinical summary modules (e.g., M2.5, M2.7 summaries, general investigational plan, M5, Safety Updates)
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Clinical Study Reports (CSRs): Synoptic, abbreviated, full CSRs, and addendums
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Clinical Study Protocols: All phases
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Protocol Amendments
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Informed Consent Forms (ICFs)
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Investigator Brochures (IBs): De novo and updates
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Safety Reports: (e.g., Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs))
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Risk Management Plans (RMPs)
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Annual Reports
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Briefing Books
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Special Regulatory Designation Applications: (e.g., Fast Track, Breakthrough Therapy, Orphan Drug Designation)
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Regulatory Responses
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Clinical Evaluation Reports (CERs)
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Performance Evaluation Reports (PERs)
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Summary of Changes
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Pharmacy Manuals
What sets me apart?
Takacs Medical Writing offers unparalleled expertise in clinical regulatory writing for biopharmaceutical companies at any stage of development. My deep experience, combined with industry-leading processes and software, enables me to tackle the unique challenges of document development, consistently delivering on time and in full regulatory compliance.
I provide comprehensive medical writing services, assisting with every phase of document development, from initial outlines to pre-publishing. My skills include adeptly coordinating content, establishing realistic timelines, managing efficient review cycles and roundtables, integrating all necessary edits, and ensuring robust Quality Control.
Should demands evolve, I can swiftly leverage my professional network to scale up resources, utilizing additional specialized expertise to meet timelines and ensure cost-effective, high-quality outcomes.
Expert Collaboration
Collaboration is at the heart of how I approach not only clinical regulatory writing, but all writing. I work seamlessly within teams to offer a wide spectrum of services.
Some of my expertise includes:
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Project Management: Carefully deploying necessary resources and managing complex timelines with others
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Quality Control and Editorial: Ensuring the final document delivery is the highest possible quality
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Document Pre-publishing: Aligning the final product with expected submission standards
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Medical Review: Consulting on the medical and scientific accuracy and appropriateness of data and study design
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Other writers/specialists to optimize project efficiency
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Publications and Medical Affairs
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Graphic Planning & Design
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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.