Regulatory Writing Services

Accelerate Your Drug Development

Regulatory writing is the critical bridge between your scientific data and market approval. At MedicoWriter, we specialize in transforming complex clinical data into clear, compliant documents that meet the stringent requirements of the FDA, EMA, and other global regulatory bodies.

Our team of expert writers understands the nuances of ICH guidelines (E3, E6, E9) and ensures that your submission documents are not only accurate but also strategically presented to minimize review cycles.

Our Core Regulatory Deliverables

• Clinical Study Reports (CSRs): Full ICH E3 compliant reports, abbreviated reports, and synopses.
• Clinical Protocols: Design and writing of Phase I-IV protocols and amendments.
• Investigator's Brochures (IBs): Annual updates and initial creation.
• Clinical Overviews & Summaries: Module 2.5 and 2.7 of the eCTD.
• Patient Safety Narratives: Comprehensive safety reporting.
• Response to Regulatory Queries: Rapid turnaround for agency questions.

Why Choose MedicoWriter?

We combine therapeutic area expertise with rigorous quality control. Every document undergoes a multi-stage review process (Scientific, Quality, and Editorial) to ensure zero-defect delivery. We have successfully supported submissions in Oncology, Cardiology, Neurology, and Rare Diseases.