The prime objective of a product monograph is to provide essential information that may be required for the safe and effective use of a new drug. It is a document which specify about the amounts of ingredients a drug or class of drugs may contain, the directions for the drug’s use, the conditions in which it may be used, and the contraindications to its use.
We at MarksMan, assimilate health professional information, scientific and consumer information to draft and design comprehensive product monograph. Our team of medical writing detail these aforementioned section with specific information to give a comprehensive overview of the product. We believe product monograph is not just about creating information that can be understood, but also about creating product information that cannot possibly be misunderstood.
Our key services for product monograph preparation:
- Research, write, develop bibliography, edit, proof and create Q&A.
- To certain that the product monograph contains all the representations to be made in respect of the new drug as required by regulatory bodies.
- Update the product monograph throughout the lifecycle of a medicine as new efficacy or safety data emerge.