Medical Writing

FEFA provides medical writing services which are performed by experts who understand the importance accuracy in documents. Medical writing, or the preparation of pharmaceutical information documents, is a complex and lengthy process, but skillfully prepared and GCP-compliant documents are the key for achieving regulatory approval. Our technical writers combine knowledge and experience to provide assistance in the production of clear and concise reports and documents according to ICH guidelines and FDA standards for regulatory review.

Pre-Clinical Writing/Scientific/Technical Writing

• Pre-Clinical Study Reports
• Pre- Clinical Sections of the IB
• Pre-Clinical Sections of INDs and NDAs
• Posters and Abstracts

Clinical Writing

• Clinical Study Reports
• Clinical Sections of the IB
• Protocols
• NDAs