Overview
Getting a new drug, therapy, or medical device to market can improve patients’ lives and a company’s standing. But navigating the complex regulatory submission process required for approval can challenge even the best companies. If your organization lacks the regulatory expertise or project management skills needed to lead the effort—or just the bandwidth—IPM can help.
Our regulatory experts will work with you to improve your process, engage your team, and drive collaboration to complete a timely submission.
Tap time-tested regulatory submission processes
Getting to market faster and with fewer headaches requires a proven process for successful regulatory submissions, along with cross-functional project leadership skills. IPM’s project management discipline and regulatory expertise make us an ideal partner to lead your submission effort.
Let us assess your needs and customize an approach, or step in to lead your current processes, to ensure a thorough and timely submission.
IPM regulatory submissions consultants will:
- Develop a sound regulatory submission approach and optimize ways of working to improve collaboration.
- Define roles and responsibilities across the organization to support your submission, involving key team members at the right times.
- Prioritize activities and workflow to stay on schedule and strengthen visibility and communication to keep everyone on the same page.
- Lead the development of high-quality submissions, avoiding common pitfalls and mitigating potential risk.
Count on IPM for Successful Regulatory Submissions
The experience IPM holds in navigating complex regulatory submissions isn’t easily obtained. Our consultants average 18 years of experience and hold credentials that include Regulatory Affairs Certification (RAC), Project Management Professional (PMP), and advanced business and scientific degrees. Since 2007, we’ve completed more than 100 submissions for more than 50 clients.
When you work with IPM, you can access the expertise you need, when you need it. Our disciplined approach and specialized expertise will turn your regulatory submission into your next success story. For on-time, on-target regulatory submissions, IPM is the answer.
Insights
ARTICLE
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