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PharmaLex.
Confidence beyond compliance.

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

When you work with us, you can feel confident that your needs have been met, your reputation has been protected, and your business objectives are on track.

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End-to-end services start here

We’re not trying to be all things to all companies. Rather, we are proud to be experts—offering a portfolio of niche services that spans 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

Let’s free up your resources

We keep your marketed products up to date, so you don’t have to.

In turn, this frees up your time and manpower to focus on new research and develop new products. 3

Saving you money

With our robust outsourcing models, we’re able 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 continually 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 1300 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

Global reach with a local presence

As expected, requirements for compliance vary depending on where you are in the world. To that end, we have offices in 21 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’re comfortable being first

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 and advanced therapy medicinal product. 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.

10 Ways PharmaLex Works Smarter For You

Who is PharmaLex and what do we do?

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

This animation will give you a short overview of who we are, what we do and how we can support your company.

PharmaLex in numbers

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Top Pharmaceutical Companies are our Satisfied Clients

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Nationalities on Staff, including former FDA and EMA experts

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Health Agency meetings annually with EMA/FDA/PMDA

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Successful projects completed

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Of our customer base represent SMEs