Why Regulatory Intelligence?
Regulatory intelligence is a critical aspect of product development and corporate strategy. It’s necessary to understand current and emerging competitors in the market, ensure compliance, and inform best practice. We’ll work closely with you to determine how regulatory intelligence can best serve your organization. Then we’ll develop a system to turn down the background noise and get you exactly what you need.
Monitoring & Tracking
In today’s fast-paced environment, it is critical to be informed of regulatory policies and activities that affect marketed and emerging products. Our monitoring services provide a fast and easy way to stay informed of regulatory changes, drug approvals, clinical trial updates, industry news, and more. Headwaters can save you valuable time and money by sending just the information you need straight to your inbox.Drug Approval Briefings
Approval briefings give your organization a thorough understanding of the Agency’s precedents for drug approvals. Briefings provide a label-based view of how a drug was approved by the FDA. We draw from drug labels, approval letters, and multidiscipline review documents, and summarize relevant and critical information in a format that is ready to disseminate.
Regulatory Intelligence Newsletters
Newsletters inform internal stakeholders of policy developments, FDA activities, and industry news that may affect your organization. We generate informative reporting with relevant information presented in a visually appealing manner, ready for company-wide distribution. Newsletters can be generated weekly, monthly, or quarterly, and are customized so that you get all the information you need—and none of the information you don’t.Advisory Committee Opinion Summaries
We can attend advisory committee meetings on your behalf and provide you with a comprehensive summary of key discussion points and voting outcomes.
Custom Services
From comprehensive summaries of advisory committee meetings to assistance with guidance documentation and other ad hoc requests, we’re ready to work with you. Let us help determine what information is crucial to your organization and how to best utilize it. Regardless of your company’s size and experience, we provide the tools to help your company develop an informed regulatory intelligence system.“In an industry with so many challenges, we face a never-ending barrage of information. From conceptualization to execution, partnering with Headwaters is a seamless endeavor. They are brilliant, responsive, agile, efficient, and professional. It is refreshing to have such an amazing partner in the truest sense of the word.”
Ready to leverage regulatory intelligence?
An initial consultation will help us find the best way to suit your needs.
