About Us

Who is PharmaLex and what do we do?

As the specialized provider, the services PharmaLex offers are essential to enable companies to maximize their development processes and reduce their time to market.

PharmaLex

Confidence beyond compliance

As the leading provider of specialized services for the pharmaceutical, biotech and medical device industries, compliance is our top priority – but it doesn’t stop there.

We strive to ensure you feel confident that your needs are being met, your reputation is protected, and your business objectives are on track.

Work with highly skilled market experts

Identify challenges

Find solutions

Accelerate your products

Gain access to resources

Stay one step ahead of regulatory requirements

10 ways PharmaLex works smarter for you

1. Delivering end-to-end services
We don't try to be all things to all companies. Rather, we are proud to be experts--offering a portfolio of niche services that span the entire lifecycle of your product..

From clinical development to marketing authorization to post-launch activities, we deliver every step of the way. We can facilitate your interactions with health authorities, find innovative pathways such as a PRIME eligibility request, as well as monitor your on-going drug safety.

It adds up to a comprehensive advantage that not only streamlines your time-to-market but also reduces your time-to-revenue.
2. Freeing up your resources
We keep your current products up to date, so you don't have to.

This frees up your time and resources to focus on research and develop to create new products.
3. Saving you money
Our robust outsourcing models enable us to offer competitive pricing coupled with a rigorous commitment to quality.

Clients can take advantage of our near-shoring capabilities in the EU (Spain and Bulgaria) or the United States (Puerto Rico), and off-shoring in Georgia or India – for a significant cost-advantage on all maintenance services.
4. Introducing new technologies into the equation
Based on our deep understanding of pharmaceutical lifecycle processes, we continuously design and improve technology-enabled services to meet ever-increasing demands. .

Our specialists employ innovative, cloud-based solutions to help you harness data, analyze findings, predict future outcomes and realize significant benefits.
5. Tapping into the entire spectrum of life sciences
When we describe ourselves as multidisciplinary experts, we’re not exaggerating.

Our team of over 3000 professionals brings an extraordinary amount of education, training and real-life experience to the table. With expertise that spans all therapeutic areas, we live and breath the science behind your products.

It’s precisely this wealth of knowledge that accelerates your ability to make more effective business decisions.
6. Supporting global reach
As expected, requirements for compliance vary depending on where you are in the world. To that end, we have offices in 32 countries. Represent 40 nationalities. And speak over 40 languages, fluently.

Ultimately, we know you need a partner who can navigate language and cultural nuances without hesitation or error, and provide a level of local insight that translates into clarity and success.
7. Partnering with the best
Expanding on our core business, we’ve built a trusted network of colleagues – PharmaLex Partnerships – unlike anything else in our industry.

Our collective expertise allows us to respond most effectively regardless of your location.
8. Customizing solutions around you
The world changes every day and so do your business needs.

That’s why we scale our solutions based on your specific situation. From smaller organizations to multi-layered, multinational companies – all of our clients are high priority.
9. We are comfortable being first
We were first to start a shared service for screening of bibliographical adverse event information. First to submit a full eCTD in a pilot project with health authorities. First in OTC switches, orphan medicinal products, advanced therapy medicinal products and more.
10. Relationships matter
Over 90% of our projects comes from repeat business.

It’s the powerful combination of big-picture thinking and targeted problem-solving that sets us apart. It’s also the fact that we genuinely like what we do and the people we work with.
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PharmaLex in Numbers

1 %
Satisfaction

9 out of 10 top pharmaceutical companies are satisfied clients

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Nationalities

Nationalities on staff, including former FDA and EMA experts

1 %
Net Promoter Score

High satisfaction scores from satisfied clients

1 %
SMES

Customers include high percentage of small-medium-sized enterprises

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