Regulatory writing is one of the most delicate and crucial aspects in the launch of new medical devices and drugs. A mistake, even a small one, in this area can lead to significant delays, additional costs and, in the worst case, the failure to launch a product on the market. If we consider the huge economic effort required for the development of a medical device or a drug, even a little delay can represent a significant damage to the manufacturing company. Here are some of the most frequent mistakes made during regulatory writing and how to prevent them.
1. Failure to include critical information
Omitting key details can lead to incomplete review or rejection by authorities.
Solution: Create detailed checklists and conduct periodic reviews to ensure completeness of documentation.
2. Use of imprecise or non-standard terminology
Inconsistent or ambiguous terminology can cause confusion.
Solution: Use standard glossaries and make sure the terms are uniform throughout the documentation.
3. Non-compliance with specific regulations
Ignorance of current regulations can lead to serious errors.
Solution: Stay up to date on current laws and regulations by attending training courses and seminars.
4. Inconsistency between documents
Having conflicting versions between different documents can lead to delays in the approval process.
Solution: Implement consistency check procedures and make sure all documents are up to date.
5. Ignoring or not taking due account of the feedback of the authorities
Regulatory authorities, such as AIFA, can provide crucial feedback. Ignoring them can lead to delays and complications.
Solution: Always pay attention to feedback, adapt the documentation accordingly and, if necessary, consult with the authorities.
Avoiding mistakes in regulatory writing is essential to ensure a smooth transition from product development to market approval. While it may seem like a daunting task, by following the guidelines above and paying attention to detail, you can successfully navigate this minefield and ensure that devices and medications get quickly and safely to the patients who need them.
If you want to learn more about our regulatory writing services, click here.