Even in the medical industry, the value of regulatory writing is often underestimated. Only when a product is recalled from the market that its importance takes prominent shape in the eyes of medical product manufacturers.
So, what is regulatory writing and how does it help companies avoid product recalls?
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What Is Regulatory Writing?
In the medical industry, regulatory writing is a part of medical writing involved in the documentation of clinical research and the submission of documents required by regulatory authorities.
Regulatory medical writers typically have a Ph.D. in different studies of sciences. They’re trained to present complex clinical trial processes and regulatory procedures in a clear and concise manner that’s easily digestible by medical professionals.
These highly skilled regulatory writers are responsible for producing well-developed, well-documented, well-structured, and well-communicated study research documents that are critical not just in the approval of a product and proof of its functionality, safety, and validity, but also in future research for the same. The skill of your regulatory writer affects the future of your product, its entry, and recall from the market.
Incorrect and insufficient documentation is often a factor of medical product recalls. The quality, ethics, and timeliness of writing positively affect the overall quality of clinical trials. A medical writer is a job as important as any healthcare job in the medical industry.
Here are other reasons why you should put importance in medical regulatory writing for your product:
1. Accurate Data Reporting Aids Correct Risk Analysis
Since it’s the job of medical regulatory writers to do factual and objective reporting throughout the trial stage of a medical product, accurate reporting means that potential risks are evaluated correctly to prevent those risks from developing even before the product reaches the public.
Hence, clinical regulatory writing–and an accurate one at that–helps companies avoid costly recalls of medical products because potential dangers from its use can be identified early on. It also gives companies sufficient time to solve the problem without the added pressure of product recall demands and everything that comes with it.
The trick is finding clinical evaluation report writers who know the balance between detailed and concise writing. For instance, measurements like subject’s height, which may be irrelevant in the main findings of a study, are often omitted in clinical publications for brevity. A good medical writer, however, knows that when a drug in a study is found to stunt growth, then that measurement will be documented so the case will be clearly articulated.
2. Clinical Study Protocols Can Help Avert Probable Problems
Medical regulatory writing includes Clinical Study Protocols, which is the single most important factor that determines the effectiveness of a medical product under study.
Protocols, which detail how treatments should be administered, how measurements should be taken, or how data collection forms should be completed, are an important quality control tool that researchers can use to validate results from all stages of a clinical trial. A comprehensive and clear study protocol can prevent confusion and steer researchers to a thorough conduct of a study.
A complete study protocol also includes deviations, modifications, and amendments made during the study. A good medical writer who’s responsible for document version control has all those written down in all affected documents and in a timely fashion because every departure from the established protocol, however slight, has the power to affect the conclusion of the study.
In other words, a well-written study protocol, as a quality-control tool, can nip all problems in the bud, preventing companies from launching products that may be harmful or defective, resulting in withdrawals and recalls.
3. Ensures You’re Following All Product Safety Standards
Regulatory bodies have established safety standards for new medical products and treatments in the market. Adhering to their requirements means you’re halfway to having products and treatments that are safe for general public consumption.
Submitting proper documentation that satisfies markers for medical safety set forth by regulatory bodies is a step towards that goal.
You Can Stop Recalls of Your Medical Products
Product recalls aren’t only damaging but also costly for the company. However, when your product is recalled from the market, your brand reputation may become the least of your worry.
Compensation demands may be something you’ll have to face, and you should feel lucky if you only have to pay for additional surgery because of a recalled product rather than face wrongful death lawsuits.
Fortunately, good regulatory writing can help you avoid medical product recalls. A clear, accurate, and complete clinical regulatory writing is your ticket to stopping recalls of your products. Thus, regulatory writing in the medical industry matters, and it’s time you appreciate the value of it.
