Regulatory Communications

foyer-meeting-358Communicating with the FDA, EMA, and other health authorities requires a clear strategy, a compelling argument, and focused preparation. PharmApprove delivers all three with a seasoned team of senior scientific and regulatory advisors and communications strategists who help you to prepare and deliver clear, concise and compelling messages — at every point along your product’s lifecycle.

The ever-changing complexities of the regulatory world demand informed and insightful advisors who can help you respond to regulators and lead the scientific conversation with clarity and flexibility.

Whatever regulatory hurdle you’re facing — a Type B meeting, a document submission, or a SAG hearing — PharmApprove’s industry-leading professionals will help you strategize and execute successful engagements with any global authority. We’ll help you optimize every regulatory interaction and shape the dialogue about your product to create a more direct path to approval.

In the US, our Principals and Communications Strategists are particularly experienced at preparing for pre-IND, end of phase 2, pre-NDA/BLA, PMA, and mid- and late-cycle review meetings. In Europe, we  assist with Scientific Advice Group meetings, Oral Explanations, market access defenses, and pharmacovigilance presentations. Our merger with NDA Group offers our clients an unparalleled breadth of global experience and expertise to drive efficient product development across the US and Europe. Learn more…