Signal Management Activities Customization
PharmaLex customizes the signal management activities, assisting with continuous monitoring of the safety data to detect, validate, prioritize, author signal assessment report, and recommend actions for signals through quantitative and qualitative reviews.
Our experts are experienced and well versed in providing responses to safety questions from the health authorities; evaluating and critically appraising ICSRs, aggregate data, and literature and thereby providing a comprehensive evaluation report.
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DownloadSMARTVIGILIT - Flyer
SMARTVIGILIT® is a web-based solution with a quality-assured environment that accomplishes all the functions related to your legal obligations for global and local literature surveillance. It independently performs weekly automated searches within PubMed or other databases. Also, safety-relevant medical and scientific literature for your products can be extracted from system by product name and time period to support all your pharmacovigilance processes at any given point in time. e.g., signal detection and PSUR(s) / PBRER(s) preparation and eventually benefit-risk evaluation (BRE) of medicinal products.
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DownloadSMARTRISK - Flyer
It is an electronic tool that allows the MAH to identify the risks presented to the quality, safety and function of each excipient in a systematic and structured approach. SMARTRISK follows the same elements to be addressed as the EudraLex guideline from 2015. This ensures that when addressed correctly the company’s excipient risk assessment meets the requirements of the European regulators. It gives a clear overview of what excipients are present in the various formulations and their associated risk relevant to the individual formulation.
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DownloadPharmacovigilance 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 QMS
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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