Importance of Regulatory Medical Writing

While researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc. in the form of safety reports, clinical and non-clinical summaries etc.

If collating the data is one side of the challenge, in such scenarios, the other side is to report it accurately and consistently to the HAs. Penning down all the details isn’t that easy, as it requires a high level of scientific understanding for easy review of documentation. In such scenarios, Regulatory medical writing would be a savior to transform the clinical study data into submission-ready and reviewable information for quick market approvals.

Why Medical Writing?

Medical device functioning, drug and cosmetic formulations, and novel foods with multiple ingredients are getting more complex with time. Considering this fact, there is a growing demand from all HAs to simplify the conveyance of such information. Especially when submitting the application and other related documents to HAs for Regulatory approvals, it is very important to ensure clarity and accuracy, as it might lead to misinterpretation of information and application rejection. With that said, how medical writers can meet the intended purposes and stand up to Agency expectations?

Meticulous Medical Writing

Medical writing is required not just to give out the science behind the product, it must ensure effective knowledge transfer concerning the efficacy of the product and medicinal product usage. Listed below are some of the common practices, a medical writer should adhere to optimize the quality of their writing.

  • Adhere to the Health Authority guidelines
  • Research and develop the domain knowledge including product development processes, clinical trial procedures, pharmacology, drug safety etc.
  • Interpret and present the research data with logical discussions and conclusions
  • Take into consideration the ethics and legal laws such as copyright issues
  • Be simple and use correlation and analogies familiar to the end-users to simplify understanding
  • Ensure the content developed addresses the common user queries
  • For clinical purposes, state the problem and content of study to describe issues
  • Explain the clinical outcomes in simple and abstract sentences avoiding jargon

Projecting clinical outcomes as accurate as they are to the HAs, and then to the end users is the first success for any product. Even a single typo or misrepresentation may challenge all your efforts of introducing an innovative medicinal product. Therefore, having a dedicated medical writing expert will help you understand the intricacies involved and push for consistency, simplicity, and accuracy in delivering the safe information to end-users. Opt for one.