PharmaLex

As part of Cencora, we provide specialized services for the pharmaceutical, biotech, and medtech industries. We guide our clients through the entire product lifecycle, from early strategic planning and non-clinical requirements to clinical development, regulatory submission, and post-approval activities. We use technology-driven solutions to support them.

Our services include Regulatory Affairs, Pharmacovigilance, Regulatory Operations, Pharmaceutical Quality, Audit / Inspection Preparation, Medical Writing, Biostatistics, Medical Devices, Risk Management, Development Consulting, GxP services, and Clinical Trial support. Our end-to-end services, which include a niche portfolio, help clients interact with health authorities, identify pathways like PRIME eligibility, and monitor drug safety. By managing current products for clients, we free up their resources for new product development.

We implement outsourcing models, including near-shoring capabilities in the EU (Spain and Bulgaria) and the United States (Puerto Rico), and off-shoring in Georgia or India for maintenance services. We design and improve technology-enabled services, using cloud-based solutions for data analysis and prediction. Our experience includes setting up shared services for adverse event screening, piloting full eCTD submissions, and working with OTC switches, orphan medicinal products, and advanced therapy medicinal products. Since our founding in 1994, 9 out of 10 top pharmaceutical companies have been satisfied clients.

We prioritize compliance in our specialized services for the pharmaceutical, biotech, and medical device industries. Our goal is to ensure clients feel confident that their needs are met, their reputations are protected, and their business objectives are on track.

We focus on Corporate Social Responsibility initiatives that center on education, empowerment, inclusivity, and sustainability. We emphasize the importance of relationships; over 90% of our projects come from repeat business.

We have a global team of over 3000 professionals. Our staff includes more than 40 nationalities and experts from organizations like the FDA and EMA. Our multidisciplinary experts have experience across various therapeutic areas.

We have offices in 32 countries, and our staff collectively speaks over 40 languages.