Biotech is our business
Strategic, insightful and proactive practical support across your product journey. You're in safe hands.
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?

A groundbreaking series of thought leadership panel discussions, featuring key stakeholders from across the life sciences ecosystem, focusing on the complex challenges in the race to bring critical, cutting-edge treatments to patients.

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.

Start-ups

Regulators

Investors

Health Authorities
Steering your product strategy; protecting your ability to innovate
Wherever 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
Marketing Authorization
Vaccines
Product Types
Due Diligence and Partnering
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.
With ATMP innovation on the rise, sponsors see increase in FDA IND holds
With more innovator companies targeting cell and gene therapy, it’s not surprising that investigational new