Medical writing
People first, Science forward.
Medical Writing
At Bion Clinicals, our MW Department is dedicated to providing high-quality, scientifically accurate, and regulatory-compliant BA/BE & Clinical trials Study Protocols & reports. With a team of experienced writers, we specialize in crafting clear and concise medical and scientific content tailored to the needs of the specific regulatory agency.
Our team is well-versed in ICH E6 (R3) guidelines, FDA, EMA, and other global regulatory requirements, ensuring that all our deliverables meet the highest standards. MW Team collaborate with our sponsor to understand your unique needs and develop customized protocols & reports. We pride ourselves on delivering high-quality documents on time, even in tight timelines, without compromising accuracy.
Key services includes:
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Protocol and Investigator Brochures:
Protocols that align with regulatory expectations and create Investigator Brochures that communicate key study information to potential investigators -
Clinical Study Reports (CSRs):
Expertly written reports that meet regulatory requirements and present your study results in a clear and structured format. -
Regulatory Submissions:
From IND applications to NDA submissions, our team is well-versed in preparing all types of regulatory documents to support your product's approval journey. -
Patient Information Leaflets:
Create easy-to-understand materials for patients to ensure they are well-informed about the treatments they are receiving. -
Manuscripts for Publication:
Assistance in preparing manuscripts for peer-reviewed journals and conferences, ensuring they are scientifically accurate and formatted according to publication guidelines. -
Medical Affairs Documents:
We provide scientific content for Medical Affairs teams, including therapeutic area overviews, clinical evidence summaries, and educational materials.
