The proper IT strategy can optimize your FDA Submission and enhance your product launch
Ed Gemo | EdGemo@barbosaconsulting.com
The proper IT strategy can optimize your FDA Submission and enhance your product launch
Ed Gemo | EdGemo@barbosaconsulting.com
Having been the CIO for several biotechs I know what IT investments are needed for a successful FDA submission and commercial launch. I can help your company make the right investments at the right time.
30+ years in the biotech industry (including being the CIO at 3 different biotechs) has given me insight into the IT platforms that help assure success for your company. I have a deep knowledge of how to manage Clinical, Regulatory and Drug Safety platforms to allow for the proper collection of documents/data needed for the FDA Submission and making sure those documents are always in a state of "control". My many years of experience working side by side with Regulatory and QA will help guide your organization to make the right technology decisions that result in a successful Pre-Approval Inspection.
My deep Commercial domain knowledge (including several successful drug launches) helps bring focus to the key technology platforms required to assure the successful launch you expect. You only get one shot at a successful launch and in today's world technology is a key component of any successful drug launch.
Securing your Intellectual Property from cyber theft is critical . Assuring that the information flowing through the organization (from your servers to the cloud and down to your mobile device) is secure is part of our review. The final report will guide you to the proper investments needed to secure your information while not limiting the creativity of your company.
The first step is to partner with company leaders to understand the current state of technology and how that technology is serving the key business capabilities. This results in a heatmap that focuses attention on the gaps.
Next we pivot the gaps identified in the heatmap process into a multi-year roadmap. The roadmap identifies the future state technology investments needed to resolve the gaps. This is the blueprint for technology success.
The last step is to look at the IT organization itself and make recommendations to address SOP/ IT Policy gaps, compliance gaps and resource gaps.
IT is often overlooked as a biotech transforms itself from a clinical stage company to a commercial entity. Identifying the IT platform gaps and compliance gaps is critical to assure that your company can secure FDA approval and have a successful launch.
We've helped many companies be better prepared for launch.
Call us or email us today to learn more.
Ed Gemo | EdGemo@barbosaconsulting.com | 917-670-2619