Is Your Approach to Regulatory Writing the Elephant in the Room?

Is Your Approach to Regulatory Writing the Elephant in the Room?

I’ve helped many clients navigate the world of regulatory writing to gain drug approvals. Our clients’ challenges remind me of the parable of the elephant and the blind men. If you’re not familiar with the story, it goes like this:

A group of blind men hear that an elephant has arrived in their village. Being blind, they have no idea what an elephant is. So, they decide to go and touch it. The blind men describe what they feel as the following:

Hey, the elephant is a pillar,” said the first man who touched his leg.

“Oh, no! It is like a rope,” said the second man who touched the tail.

“Oh, no! It is like a thick branch of a tree,” said the third man who touched the trunk of the elephant.

“It is like a big hand fan” said the fourth man who touched the ear of the elephant.

“It is like a huge wall,” said the fifth man who touched the belly of the elephant.

“It is like a solid pipe,” Said the sixth man who touched the tusk of the elephant.

They began to argue about the elephant, and every one of them insisted that he was right. A wise man was passing by and he saw this. He stopped and asked them, “What is the matter?” They said, “We cannot agree to what the elephant is like.” Each one of them told what he thought the elephant was like. The wise man explained to them, “You are all correct. Every one of you is telling it differently because you each touched a different part of the elephant. So, actually, the elephant has all those features that you all said.”

My clients are bright, talented individuals. They are committed to bringing innovative new therapies to patients. But, working in silos means that they do not have perspective on the entire process. A full service regulatory writing team can help them increase their efficiency and profitability.

Telling your drug’s story

You put blood, sweat, and tears into developing a new treatment for patients. But, regulatory agencies don’t see all your years of hard work. They only see the documents that you submit. These documents must guide the reviewer through the research demonstrating the drug’s safety/efficacy profile.

Companies often assemble teams lacking experience bringing a drug to market. Engaging a partner experienced with the entire regulatory process can reduce time lines and expenses. This partner can help drive your team to success by:

  • Planning the approach early in development
  • Organizing the team’s collective knowledge into briefing documents and submissions
  • Managing questions from health authorities

Meeting your partner’s team

Who are the players on your partner’s team? How do they work together to support drug approvals?

  • Project leads: They assess the requirements of each project. They work with consultants to develop detailed plans to address your deliverables and deadlines. Then, they hand pick the team that matches the skills necessary for each particular job.
  • Regulatory writers: They form the foundation of the team. Regulatory writers complete all documents to time, budget, and quality. Superior writers have strong writing and editing skills. They often have advanced scientific degrees and know the requirements of regulatory documents. Regulatory writers vary widely in their experience and skills. They are chosen to support particular documents based on their skill set.
  • Submission leads: This team member knows best practices for crafting regulatory documents. He designs the story board and works with the team to transition the target product profile (TPP) to the proposed product label. He sets strategic messaging and ensures consistency across the program. He also leads and facilitates discussions between the sponsor and writing team. In addition, the submission lead suggests the best ways to present data and guides document reviews. He might even suggest an innovative analysis strategy.
  • Subject matter experts: Some writers have extensive experience in a specialized aspect of drug development. These writers might know a lot about documents for pediatrics or rare diseases. Others specialize in a certain therapeutic areas such as oncology or infectious disease. A subject matter expert can provide advice on the same challenges your drug may be facing.
  • Document quality associates: This team member conducts a rigorous in-house quality-control check. QA/QC ensures that writers perform work right the first time. We maintain an internal database of styles, templates, and guidelines. It includes best practices required by regulatory bodies and by specific clients. This database gives us an unrivaled advantage in:
    • Managing client requirements
    • Ensuring adherence to guidelines
    • Keeping writers and editors current on industry best practices.

Partner with a regulatory writing services team early in your planning to reap all of these benefits.

Gain a strategic advantage through engaging experts in regulatory writing

To learn more about the Synchrogenix approach, please read this case study. It shows how we helped a client prepare and summarize Common Technical Document (CTD) Modules 1-5 in less than 5 months. What struggles are you facing in developing a regulatory strategy? Let me know in the comments section!

Steve Sibley

About the Author

Steven Sibley is the Vice President of Global Submissions and Submission Leadership at Synchrogenix. With a career spanning more than 20 years in the pharmaceutical industry, Mr. Sibley has extensive regulatory and writing experience, preparing a wide variety of both nonclinical and clinical documents and leading project and submission teams.