The Biopharma Excellence team has deep experience with cell and gene therapies and is working hand in hand with us to help realize our ambitious vision.
Where do you need our help?
Bridging the Biotech / Regulator Divide
We help dynamic biopharma companies bring innovative new therapies to market in the smartest, smoothest and safest way possible.
We work closely with biopharma businesses, international regulators and health authorities, and potential investors, to confidently optimize the market potential of cutting-edge biotech innovation.
Our team is a fusion of three scientific powerhouses, Pharmalex, ERA Consulting and Biopharma Excellence – under the PharmaLex brand. We combine 35+ years of empirical experience and respected regulator relationships.
Steering your product strategy; protecting your ability to innovateWherever you are on your journey as a biotech – whether you’re still forming your team or seeking funding or putting together marketing authorization submissions – we’ll apply our deep industry and regulatory expertise to optimize your opportunity. We can help you across every stage of your product and business lifecycle, spanning:
Regulatory Agency Interactions and Clinical Trials
Non-Clinical and Quality
Establishing a Strategy
Due Diligence and Partnering
Insights HubSharing 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.
Biopharma’s Big Inflection Point: There’s never been a better time to innovate with next-generation medicine
by Christian K. Schneider, MD
In all of the years I have been tracking and helping to drive...