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Pharmacovigilance Services postcard
Place your Pharmacovigilance, and Safety surveillance activities in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource end-to-end global and local Pharmacovigilance activities – our knowledgeable experts will be there for you no matter where you are.
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DownloadCommissioning and Qualification (C&Q)
PharmaLex offers full support along the Commissioning, Qualification and Validation Lifecycle (VLC) for your new or modified facilities, equipment, and systems. Our Commissioning & Qualification (C&Q) professionals are experienced in each deliverable from the C&Q portion of the VLC; i.e. the V-Model, as established by ASTM E2500 and ISPE‘s GAMP 5.
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DownloadRegulatory Compliance - CMC Implementation
Implementing a sustainable approach to the CMC compliance process. CMC compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors.
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DownloadHealth Economics
Early advice on health economics, reimbursement and market access strategy.
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DownloadBiosimilar Quick Links and Guidelines
Links to Biosimilar guidance by national authority
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DownloadMedical Information Services
Our extended product portfolio can serve various needs and varies from service models that help to streamline and support internal processes to successful product launch.
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DownloadPortfolio Maintenance Outsourcing
PharmaLex provides a viable Strategic Outsourcing solution, capable of maintaining your products throughout the life cycle while…
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DownloadWriting Capabilities
PharmaLex offers a number of writing services, covering technical writing, regulatory writing, medical writing and scientific writing.
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DownloadReal World Evidence
In contrast to the controlled and homogeneous setting in RCTs, the real-world setting consists of a broader and more representative patient population, where treatments are not necessarily used in accordance…
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DownloadGxP - Operate a functional and efficient Quality Management System
A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical…
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DownloadValue Added Medicines
Value Added Medicines developments aim at enhancing well-established, off-patent molecules by optimizing their efficacy, tolerability, or ease of use or even exploring them in new indications.
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DownloadOrphan Medicine Development
Orphan medicines are intended to treat rare diseases. Both, the EU and US drug legislation have financial and regulatory incentive systems in place to…
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DownloadAdvanced Therapies - Navigating through the Regulatory Framework
The ATMP regulatory framework in the EU and the US framework programs for cell-based or gene therapy products are complex…
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DownloadBiopharmaceuticals CMC
Biopharmaceuticals are an unprecedented success story. Due to their outstanding efficacy and safety and their high potential to address unmet medical needs, biopharmaceuticals are by far the…
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