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Discovery / Non-clinical
PharmaLex Overview of Services
We are global provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance.
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DownloadHealth Economics
Early advice on health economics, reimbursement and market access strategy.
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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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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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DownloadWriting Capabilities
PharmaLex offers a number of writing services, covering technical writing, regulatory writing, medical writing and scientific writing.
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DownloadClinical Development
PharmaLex Overview of Services
We are global provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance.
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DownloadBiosimilar Quick Links and Guidelines
Links to Biosimilar guidance by national authority
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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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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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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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DownloadWriting Capabilities
PharmaLex offers a number of writing services, covering technical writing, regulatory writing, medical writing and scientific writing.
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DownloadChemistry, Manufacturing and Control (CMC)
Our CMC group provides regulatory guidance in setting specifications, method development and validation of documentation. We can help you build a positive relationship with…
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DownloadPost-approval / Maintenance
PharmaLex Overview of Services
We are global provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance.
Posted:
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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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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DownloadRegulatory Compliance
Pharmaceutical companies are marked by factors such as external changes in the regulatory environment and internal Merger & Acquisition programs, entry into new markets (especially non-ICH regions) or changes…
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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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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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