Blog & Article
- 27th April 2025
Fact Flyers related to Regulatory Affairs and CMC
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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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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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The switch to eCTD 4.0 will require an update to the eCTD tool but could also have an impact on Content Management Systems and will change how applications are reviewed and approved.
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You’ve already invested so much in your life-changing therapy. Don’t leave its success to chance. Lean on deep regulatory expertise throughout your product’s lifecycle to manage global complexity, and strengthen your market approach.
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As an outsourcing and consulting services company, PharmaLex is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. These flexible solutions range from an integrated package of services to adapted adhoc regulatory and technical support. Our goal is to explore innovative approaches and provide relevant advice to ensure you maintain your competitiveness in this complex and changing regulatory environment.
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PharmaLex offers full lifecycle management for the submission process with flexible options for report-level publishing, compilation of major applications (IND, NDA, BLA) and lifecycle maintenance. Our regulatory affairs professionals are experienced in an array of electronic formats, including electronic Common Technical Documents (eCTD), and Structured Product Labeling (SPL).
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Meetings with the leadership and review staff of the US Food and Drug Administration (FDA) are one of the most important resources available to sponsors seeking agency approval in the US. PharmaLex recommends holding face-to-face and teleconference meetings with FDA throughout the product development timeline.
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Our CMC group provides regulatory guidance in setting specifications, method development and validation of documentation. We can help you build a positive relationship with…