Fact Flyers
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The demands on scientific and regulatory documentation are continuously increasing. Pharma and biotech companies in Germany face the challenge of producing high-quality medical writing documents without overloading internal resources. Choose PharmaLex to reduce costs, navigate regulatory challenges, and respond flexibly to market changes.
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PharmaLex’s Post-Launch Outsourcing services deliver cost-effective regulatory lifecycle maintenance of established products – from full portfolio to country-based outsourcing. Growing regulatory complexity and mounting cost pressures in today’s hyper-competitive global market mean companies can struggle to sustain post-launch product revenue streams. Increasingly, organizations of all sizes are strategically outsourcing the regulatory management of established product portfolios to stay competitive, flexible and innovative
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We help you elevate your market access strategies with tailored solutions. Our collaborative approach delivers tailored strategies and support for your product journey.
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Our Drug Substance Service support offers specialized expertise to navigate the complex landscape of regulatory approvals
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We support you in defining and executing optimal strategies for the EU Clinical Trial Regulation implementation
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Our Access Consortium procedure service offers comprehensive support for all five health authorities: Australia (TGA), Canada (HC), Singapore (HSA), Swissmedic (SMC) and UK (MHRA).
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Developing a biosimilar requires a full set of both experience and expertise in terms of manufacturing, development, clinical, regulatory and market access.
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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.
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Our quality management and compliance team understands the complexities and demands of the pharmaceutical industry, especially in the Nordic region.
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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.
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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.
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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.