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Regulatory Operations Department Developed and Flourishing

In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. The staff to manage and support this group was secured. Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed. The software was validated to ensure 21 CFR Part 11 compliance and the associated standard operating procedures were finalized.

The group successfully submitted a “pilot” eCTD submission to the Food and Drug Administration (FDA) and gained FDA approval to transmit submissions through the Electronic Submissions Gateway (ESG). By early 2014, the Regulatory Operations group was fully operational and ready to offer electronic publishing services to IMPACT’s clients.

An independent regulatory consultant, who happened to be a former colleague of an IMPACT staff member, approached the company about the new electronic publishing services. This consultant represents several small pharmaceutical/biotech companies throughout the country.

This consultant has used other publishing providers for her electronic submissions but was searching for a new provider. While working with the other publishing providers, the consultant frequently had to address technical issues that should have been managed by the publishers. The consultant wanted a group that had the knowledge, experience, and capability to fully manage the “technical” side of eCTD submissions.

Because of this, the consultant began to look for a team who would assume full responsibility for publishing and submitting her regulatory submissions, thereby allowing her to focus on regulatory affairs and strategy. She chose IMPACT’s Regulatory Operations group since she felt the staff had the knowledge, experience, and training to become a valued addition to her team.

To date, IMPACT has published 3 initial Investigational New Drug (IND) applications for this consultant, on behalf of 2 Sponsors, and is currently managing the IND lifecycle management for 6 INDs. During the last year, IMPACT has submitted several FDA meeting packages for this consultant as well.

In addition to the eCTD publishing services, IMPACT has provided multiple training classes to this consultant’s clients on authoring templates, MS Word, and eCTD viewer software.

IMPACT’s personnel have become trusted team members of this consultant’s team, which has resulted in a “win-win” situation for both parties.

I have been an independent Regulatory Affairs consultant in the pharmaceutical industry for over 16 years. Many of my clients are small start-up companies with limited internal resources. When these clients need a team to prepare their regulatory submissions on paper or as eCTD, I always recommend IMPACT. Being able to place my full trust in IMPACT’s technical skills, submission management expertise and eCTD submission experience allows me to focus more on my role as a global regulatory affairs strategist and product development advisor, which includes a busy international travel schedule to support my clients.

I had been involved in regulatory operations for more than 25 years and I am continuously impressed with IMPACT’s Regulatory Operations group’s diligence to get even the most complicated submission done on time and with the highest quality. Over the last 18 months, they have created and submitted several initial IND applications and converted two paper INDs to eCTD for my clients and are now managing the lifecycle for these INDs. The dedication of IMPACT’s team led me to encourage one client to change publishing providers and to go with IMPACT. They have become an extension of my client’s team. I would recommend IMPACT without reservation to any company that needs a group to manage and prepare their eCTD submissions. Truly IMPACT is a dream regulatory support team that every independent Regulatory Affairs consultant needs.

Independent Regulatory Affairs Consultant