Strategic Regulatory Writing for Drug Development Success

Strategic Regulatory Writing for Drug Development Success

Happy New Year! The start of a new year brings the promise of new opportunities for growth—both personally and professionally. As the CEO for Synchrogenix, Certara’s regulatory writing consultancy, I’ve been thinking a lot lately about how changes in the regulatory writing landscape will shape the drug development process in 2015. It’s becoming more and more apparent that a well-thought out approach to developing high quality submission documents is essential to the successful development and approval of new therapies. In this blog post, I’ll discuss what regulatory writing encompasses as well as how to turn it into a strategic asset.

Regulatory agencies expect high-quality documentation throughout the drug development process

As an investigational drug proceeds from pre-clinical to clinical studies to approval, there is associated regulatory documentation at each step. During pre-clinical development, there is often a need for reports summarizing the results of pharmacological, toxicological, and ADME studies. Presenting a pre-clinical program to global regulatory authorities often requires developing:

  • Pre-IND/Pre-CTA briefing documents and meeting materials
  • eCTD-compliant written and tabulated summaries for Section 2.6 First Time in Man packages: Initial Investigator’s brochures and FTIM protocols
  • Strategic writing of Modules 1 through 5 of the IND eCTD for reusability IMPD submission

Moving a candidate into clinical trials means complex documentation and disclosure requirements

Most people are familiar with the different types of clinical regulatory documents including:

  • NDA/MAA/BLA/ANDA
  • Clinical study reports (CSRs)
  • Narratives
  • Protocols

Our experience and areas of expertise encompass Common Technical Document (CTD) Modules 1-5 and global dossiers, including development plans, investigator’s brochures, protocols and CSRs, summary documents, briefing packages, and documentation to meet ever growing transparency and disclosure requirements.

Moreover, Synchrogenix has the experience and know-how to take on large and complex projects, to develop and manage the critical path, and to drive the team— including the sponsor, other vendors and our writers and consultants—to delivery. We are unmatched in this ability.

There is often less familiarity with clinical trial transparency initiatives. Over the past several years, regulatory agencies have pushed the pharmaceutical industry to disclose more and more information in the public domain. Therefore, clinical trial registration and disclosure requirements detailed in FDAAA and FDAMA  have created an enormous volume of work that many organizations are not equipped to handle. As a result of seeing companies struggle to integrate these requirements into their processes, we developed not only the skill set, but also the process to integrate clinical trial registration and disclosure into our clinical writing services.

What turns regulatory writing from a commodity to a strategic asset?

Working with a great team is a pre-requisite to success in any venture. At Synchrogenix, I’m proud to work with highly skilled regulatory writers and editors. Our writers have an average of 14 years of experience. This depth of experience means that our team members know how to ask the right questions to provide solutions in accordance with CTD requirements and regulatory guidance.

Unlike many of our competitors, we are not a virtual company. Our employees work in our offices in North America, Europe, and Asia, facilitating our team-based methodology and ensuring that our clients have access to 24/7 support.

Joining forces with ClinGenuity to better serve our clients

One of the changes that I’m the most excited for this year is our acquisition of ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Our combined team will now include more than 200 regulatory and medical writers with expertise in document development for the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global regulatory organizations. Synchrogenix has historically focused on regulatory writing services. With this acquisition, we will broaden our capabilities to develop clinical information for other audiences, including health care providers, patients and the community. When great leaders and companies combine to complement and enhance each other, better services and unique ideas emerge. I am confident that the combination of cutting-edge technology, along with a dedicated team of highly skilled and experienced writers, will help increase new drug and medical device development efficiency, and thereby reduce development cycle times.

Recently, we were approached by a client to write 6500 narratives in 6 weeks, based on a post-approval request from the health authorities. The final solution to this difficult challenge was so great that I’d like to share it with you in this case study. I hope that you’ll read it and let me know what you think. What are YOUR New Year’s resolutions regarding how you’ll change your approach to preparing submission documents for global regulatory agencies in 2015?

Kelley Kendle

About the Author

Ms. Kendle is the President of Synchrogenix. She drives the company's strategic growth, business processes, and organizational dynamics. Ms. Kendle has a strong educational background in Operations Management, Economics, Business Administration, and Finance and is an expert in understanding the challenges and needs of organizations in highly regulated industries, such as the pharmaceutical and biotechnology industries.