Fact Flyers
Fact Flyer
Our highly professional and experienced IVD & medical devices team, together with our expert biostatisticians, can support you from initial concept development through to formal design and product release.
Fact Flyer
We guide you from early strategic planning activities through product development, regulatory submission processes and post-approval / maintenance / post-launch activities. Our experts use technology-enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.
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PharmaLex brings a global reputation for excellence and trust built on decades of experience in quality, regulatory affairs and strategic consulting services. We are leaders in IVD global regulatory compliance.
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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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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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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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Radiopharmaceuticals in diagnostics and therapy form a special product group with specific regulatory requirements in terms of production, distribution, and radiation protection. Necessary safety precautions and often very short half-lives pose special challenges for the business and require a different conceptual approach compared to „conventional“ medicinal products.
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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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PharmaLex offers full support along the Validation Lifecycle (VLC) for your New Product Introductions and Technology Transfer projects. Our Validation Professionals are not only validation experts, but process experts. And by this we mean experts in all types of manufacturing processes for all types of dosage forms.
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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.