Regulatory Writing Services

Person Working on Regulatory Writing Document with Laptop, Journal, and Stethoscope

Essential Data Corporation provides unparalleled regulatory writing services, and understanding what those services could look like for your company is a key first step.

Regulatory document writing within the pharmaceutical industry includes long processes and documentation to write manuals, drug information, and educational medical brochures. The importance of regulatory writing services is to help expedite the process of clinical documentation required for a drug’s information and safety measures. 

What is Regulatory Writing? 

Regulatory writing is the development between the preclinical and clinical research procedures that will be implemented into written documentation. Within the documentation, technical writers go in-depth about the process of the pre-trials, and clinical trials, including the safety measures during the trials and after the trial.

Five Practices in Regulatory Writing

To create efficient documents for the readers to be engaged, there are five practices in regulatory writing to follow:

1. Clarity of Story

Be very concise, descriptive, and clear on what you are discussing. The document should be understandable for the reader.

2. Simplicity of Story

Using simple words and phrases is the key to regulatory writing. Writing over-complicated words and phrases may confuse the reader and question the tests that were performed.

3. Cosmetically Flawless

In simple terms, proofread. As a technical writer, or any writer in general it is important to proofread and edit your work. Even though it may not be a requirement for regulatory writing, it is important to keep the reader engaged instead of focusing on grammar and spelling errors.

4. Sufficient Context

Most times, some of the readers would not want to read the whole documentation. It is the job of the regulatory writer to cross-reference the topic throughout the documentation without being repetitive. 

5. Unity of Voice

The document should not sound like there is more than one writer. Be cohesive while writing on the regulatory writing.

What is the Difference Between Regulatory Writing and Medical Writing? 

Medical writing and regulatory writing are similar in the sense of both being written documentation that documents the details of clinical trials and safety of a given drug. However, regulatory writing mostly consists of writing and understanding the regulatory guidelines when they continue the process. On the other hand, medical writing requires knowledge of clinical documentation and therapeutic areas, the development process of pharmaceuticals, and drug safety. Both are incredibly important, and having a highly-skilled technical writer on board ensures that job gets done right.

EDC Technical Regulatory Writing Experts

Looking to learn more about Essential Data’s capabilities and the benefits of regulatory writing? Check out some of our related articles below:

Whether you need a single regulatory writer for a brief project or a team of technical writing consultants to produce a complete line of documentation, the quality of our work is guaranteed for you. Our clients work closely with an Engagement Manager from one of our 30 local offices for the entire length of your project at no additional cost. Contact us at (800) 221-0093 or to get started.