Biotech is our business

Strategic, insightful and proactive practical support across your product journey. You're in safe hands.

Get In Touch Discover Insights

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?

Developing your drug candidate
Navigating the international regulatory landscape
Getting a new therapy into clinical trials
Applying for marketing authorizations

The Science Huddle

A ground-breaking forum that brings together those at the front line of cutting-edge life sciences to identify practical ways forward to bring critical treatments to patients.

Reserve your place for the next Science Huddle

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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.





Health Authorities

Biopharma Excellence are pioneers. They’re one of the first ‘recognizable names’ in this industry. They bring entrepreneurial spirit.
Senior Vice President, Pioneer Engineered iPSC
Something that really sets Biopharma Excellence apart is its people. They’re scientists, but much more than that.
Senior Vice President, CMC, Gene Therapy Company
The team at Biopharma Excellence are powerful story-builders and story-tellers. They write submissions regulators WANT to read.
Chief Executive Officer, Large Molecule Biotech Company

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.
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ICH’s viral safety guidelines catch up with the latest biotech innovations

More than 25 years after adopting the first version of the guideline on the viral

Start a conversation today