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“Our clients have always been our top priority!”

“We lead where others follow, helping clients to go beyond compliance, capitalizing on greater efficiencies, streamlining complexity and delivering true business value.”

Pharmaceutical industry experts with flexibility.

These principles form the values and the business approach that PharmaLex was founded on, and are still true today. PharmaLex prides itself on becoming an extension of your team; with the quick turnaround, expertise and flexibility needed to support your goals.

PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities.

Our success is built upon four key values

We deliver subject matter experts and tailored solutions, whether working onsite or remote. We offer innovative solutions that help manage risks and optimize processes.

“PharmaLex has been our strategic outsourcing partner for over 10 years. As our needs have evolved over time, so has PharmaLex. They have always delivered the right experts who can advise and guide our teams at different sites.”

VP, Multinational Company

Our staff — 80% of whom have over 20 years of industry experience — collaborate on world class NCE, NBE, OTC, biopharmaceuticals, and more. We quantify our efficiencies with KPIs installed for each project. Deliverables are tracked to be on time, in budget and to successfully pass clients’ internal review.

“The PharmaLex team are trained on our SOPs and know our company. They provide recommendations for improvements and suggestions in a very constructive partner-like, and most importantly, pro-active manner. We have very unique and strict SOPs, and PharmaLex always finds quick solutions and make them happen. Most importantly, they provide savings without jeopardizing the quality of the output.”

Senior VP, Global Pharmaceutical Company

We thrive on navigating a highly regulated environment utilizing some of the most experienced professionals in the field. We have worked on strategic products of world class medications in areas including anti-infectives, biosimilars and regenerative medicines.

Our staff are passionate about their field and the majority have been in the industry for more than 20 years, including previous former government health agency employees (FDA and EMA).

“Having PharmaLex dedicated experts on hand, who know my business inside and out has been truly game changing. I am always happy to recommend them to my colleagues.”

Medical Director, Biopharmaceutical Company

We are built on local teams that are committed to excellence and delivering the highest standards of service. We have a 95+% continuation rate. Once clients have worked with us, they stay with us understanding the value-adding role we bring to their success.

“It’s really important for us to have local language experts that can easily slot into the existing team. PharmaLex has been integral to the success of our business.”

Managing Director, Global Biopharmaceutical Company