Blog & Article
- 28th March 2025
Fact Flyers
Fact Flyer
We help you elevate your market access strategies with tailored solutions. Our collaborative approach delivers tailored strategies and support for your product journey.
Fact Flyer
Our Drug Substance Service support offers specialized expertise to navigate the complex landscape of regulatory approvals
Fact Flyer
We support you in defining and executing optimal strategies for the EU Clinical Trial Regulation implementation
Fact Flyer
Our Access Consortium procedure service offers comprehensive support for all five health authorities: Australia (TGA), Canada (HC), Singapore (HSA), Swissmedic (SMC) and UK (MHRA).
Fact Flyer
Developing a biosimilar requires a full set of both experience and expertise in terms of manufacturing, development, clinical, regulatory and market access.
Fact Flyer
Our Affiliate PV solutions help biopharmaceutical companies of all sizes navigate complex regional and local PV regulatory requirements – driving growth in existing as well as new markets worldwide.
Fact Flyer
Our quality management and compliance team understands the complexities and demands of the pharmaceutical industry, especially in the Nordic region.
Fact Flyer
Many companies face challenges in managing complex trial designs, interpreting diverse datasets, and meeting regulatory expectations – especially in fields like rare diseases and pediatric studies. Navigating this complicated landscape demands deep clinical development experience and knowledge.
Fact Flyer
Our SaaS solutions are the outcome of two decades of expertise and development and used by a broad range of biopharmaceutical companies with success. SMARTSTATS is an umbrella software consisting of modules that facilitate report writing in line with regulatory guidelines and authority (EMA/FDA/MHLW/…) expectations.
Fact Flyer
Embark on a journey of innovation and excellence with PharmaLex’s Data Strategy and quantitative sciences team. We specialize in delivering comprehensive biometric services tailored to supporting the entire lifecycle of medical product development.
Fact Flyer
Chemistry, manufacturing, and controls (CMC) describe critical activities during development and regulatory approval of pharmaceutical and biopharmaceutical products. PharmaLex’s data strategy and statistics dedicated team specializes in leveraging an integrated data-and-analytics approach to accelerate quality throughout the drug development and production lifecycle.
Fact Flyer
Experience the power of data-and-analytics seamlessly woven into every phase of your journey, from discovery to market access. At PharmaLex, we redefine possibilities with our innovative approach to data strategy and quantitative sciences.