What is “good” regulatory writing?

By Justin Burning

Global is in the communications business. Everything we do comes down to this: We help our clients identify the story they need to tell and the best way to tell it, then we help write it. Whether our client wants to put a device on the market, submit for drug approval, or document a clinical trial, a well-written regulatory document smooths the path toward their goal. 

At heart, many in our industry are scientists. Our bedrock is data, but data on their own are not necessarily convincing or even comprehensible. In writing terms, data are the raw vocabulary. The regulatory writer exists to synthesize and organize this vocabulary into the sentences, paragraphs, and chapters that constitute a clear, supportive narrative: this device is safe and effective when used as designed, the development and manufacture of this drug is transparent and reproducible, these were the documented successes and failures of the clinical trial. 

Though there are skill overlaps between great scientists and great writers, the regulatory writer excels at filling the gaps so that the benefits of brilliant products are brilliantly realized through good regulatory writing. 

“Good” regulatory writing: 

1. Demonstrates essential knowledge of the technical subject matter and of the regulatory reporting expectations for that subject matter 
2. Synthesizes information from a wide pool of knowledge down to its salient points and key messages 
3. Provides organization that amplifies impact 
4. Communicates important results and WHY they are important 
5. Allows easy comprehension by regulatory bodies, streamlining approval processes, saving time, money, and, potentially, patient lives 

A very important element of effective writing of any kind, particularly regulatory writing, is an awareness of the audience. It is essential that regulatory writers are familiar with and craft their product to reflect the guidance and regulations from health authorities. Time spent gathering intelligence and seeking to understanding what health authorities are looking for – for your product, at this particular point in its development lifecycle – helps to ensure your investigator’s brochure, clinical evaluation report, clinical study report, common technical document, etc., addresses all requirements and avoids setbacks to approval. 

Often, these expectations are wide-ranging and touch on many elements of a clients’ operations. A skilled regulatory writer works across the seams to bring different points of view, from the laboratory to the production line to marketing, into a coherent story that supports the client’s goals and satisfies the needs of health authorities, while at the same time minimizing the reporting burden across the product lifecycle. Besides writing, the regulatory writer must listen intently, to draw out pertinent empirical evidence from across the spectrum of operations. Additionally, strong regulatory writing leverages peer-reviewed information that can provide precedent and reinforcement. 

Taken together, a sound regulatory writing strategy can facilitate an easier and more successful path to licensure. A robust data set is only as persuasive as the words presenting it; an investment in proven regulatory writing can make sure exceptional scientific work is reported exceptionally.