vishals99

I am a Medical Writer & Clinical Documentation Specialist with 6+ years of expertise in regulatory writing, clinical trial documentation, and eCTD submissions. Skilled in crafting comprehensive, compliant, and high-impact regulatory and scientific documents, I ensure precision and clarity in every submission.

My expertise spans clinical study reports, investigator brochures, protocols, informed consent forms, regulatory dossiers, and medical manuscripts, aligning with FDA, EMA, ICH-GCP, and ISO standards. I specialize in translating complex scientific data into clear, structured, and regulatory-compliant documents.

With a strong commitment to accuracy and adherence to industry guidelines, I help organizations streamline submissions, enhance compliance, and accelerate approvals. Whether you need clinical, regulatory, or scientific content, I deliver well-researched and meticulously written documents tailored to your needs. Let’s collaborate for excellence!