Regulatory Agency Interactions

Get In Touch

Regulatory agencies globally provide numerous opportunities for sponsors to engage with them during the development process. We’ll help you access the right advice on significant scientific, technical or clinical issues, or to simply check alignment with regulatory agency expectations.


We’ll help you secure constructive regulatory agency feedback early in the development process–or as appropriate, as issues or queries arise. By facilitating valuable discussions from an early stage, we’ll help ensure alignment on these and other key aspects of the development program, to maximize the outcomes.


Getting the most out of agency meetings


We’ll make sure you maximize regulatory agency interactions, ensuring strong alignment and efficient progress from development to market access. Our experts can support all aspects of agency interaction–from strategy development to briefing book preparation. We can also take the lead in regulatory agency meetings.

We understand what it takes to navigate clinical and regulatory complexity and deliver new products to the market, and can help field questions and avoid issues, optimizing time and resources. We’ll ensure that each clinical and regulatory strategy, and every agency interaction, fits the target patient population and indication to maximize regulatory success.


Get In Touch

Insights Hub

Sharing insights, questioning norms, asking the right questions - we'll never lose sight of what you're striving for. Our insight and expertise will help you bring the most innovative therapies within reach of patients around the world.
Placeholder Image

Cell & Gene Therapy: Maximizing Commercialization Potential

How to Navigate the Less Obvious Barriers to Brining Advanced & Highly Targeted Treatments to

Start a conversation today

If you’re developing something truly ground-breaking, Biopharma Excellence is the nearest resource you’ll find to someone who’s been there before.


    We are now Cencora PharmaLex 

    PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. In 2024 and beyond PharmaLex and all the companies in PharmaLex family will begin a journey to becoming Cencora as well. Cencora brings the companies and services together under one new name. The name will change, but the level of attention and service you receive remains the same.  

    Know more