Let IPM regulatory experts lead your cross-functional team to successful and timely regulatory submissions that meet your strategic goals and customer needs.
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.
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:
An assessment of your current operational submission process is the right place to begin. With IPM’s proprietary approach, we determine your readiness for regulatory submissions. We’ll evaluate your current methodologies and tools with an eye on improvement through project and change management. A roadmap with prioritized recommendations for process improvements will guide you as you move forward.
If you don’t have a regulatory submission process established, or if you are looking to enhance your current process, IPM can help. Based on experience gained through more than 100 submissions, we will design a customized approach for your team. We’ll work with you to establish your team structure, document the process, define roles and responsibilities, provide governance oversight, and establish communication strategy. When you bring in the right people at the right time to work on the regulatory submission, efficiency soars.
IPM is ready to lead you through a wide range of regulatory submissions, from investigational new drug applications (IND) to late–stage submissions such as new drug applications (NDA), biologic license applications (BLA), and abbreviated new drug applications (ANDA). For companies seeking approval on the international market, we are well–versed in clinical trial applications (CTA) and new drug submissions (NDS) in Canada, marketing authorization applications (MAA) in the EU, and more. Medical device manufacturers will be guided through 510(k) premarket submissions and premarket approval (PMA). IPM’s consultants will ensure a high–quality submission is completed on schedule and meets the strategic needs of the organization.
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.
Benchmarking submission processes against the industry can help you improve performance and manage executive expectations. IPM’s regulatory experts have crunched the numbers.