Medical writing in pharma plays a critical role in the drug development process. Regulatory writing involves preparing documents that must be submitted to regulatory agencies to seek approval for a new drug or indication. This includes clinical study reports, investigator brochures, and summaries of safety and efficacy data. Skilled medical writers can help pharmaceutical companies to develop clear, accurate, and effective communication materials that support the development and promotion of new therapies.
List of our Services:
- Writing and/or reviewing clinical trial protocols
- Writing clinical study reports (CSRs) that summarize the trial results
- Developing manuscripts for publication in scientific journals
- Reviewing and/or writing clinical trial regulatory documents, such as Investigator Brochures (IBs), Patient narratives and New Drug Applications (NDAs)
- Collaborating with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to ensure that all documents and reports are written in compliance with regulatory guidelines and industry standards
- Conducting literature searches and reviews to support the development of clinical documents
- Presenting study findings to internal and external stakeholders, such as study sponsors, regulatory authorities and scientific conferences
- Ensuring that all documents and reports are written in a clear, concise, and accurate manner that is appropriate for the intended audience
