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Time is rapidly running out to transition ongoing clinical trials in the EU to the new framework of the Clinical Trials Regulation (CTR). A key challenge for sponsors is ensuring they are proficient in the Clinical Trial Information System (CTIS) and understand the transition requirements.
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SmartSTATS\Enoval integration into method development and validation workflows allows our customers to significantly improve the efficiency and quality of the validation processes.
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PharmaLex is your one stop source to instantly accelerate the development of innovative small molecules from R&D to market.
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Non-clinical development includes providing advice to clients in terms of non-clinical study requirements to support various phases of clinical development of active drug substance and subsequent marketing authorization. This includes types of pharmacology, pharmacokinetics, and toxicology studies; their timing/sequence, and an outline of the study design.
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Our highly professional and experienced regulatory affairs and compliance teams are available to provide support as required. Our team members’ experience includes Regulators, Notified Bodies and Industry covering a wide range of products.
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The new outsourcing paradigm is built on a tailored, blended model of in-country, near-shore, and offshore resources, ensuring that partner domain experts are seamlessly integrated into the biopharma company and oversight of the portfolio is centrally managed. We build our synergies on the foundation of expertise, knowledge, and innovation – which ultimately leads to efficiency and cost reduction for clients.
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Drug development requires the integration of many different, yet interrelated activities. Without a clear destination and roadmap your journey to the market will cost more and take longer than expected. An integrated development approach reduces cost and complexity while helping to ensure commercial success.
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Meetings with the FDA are extremely beneficial to build a relationship that will last many years Meetings with the US Food and Drug Administration (FDA) help you create a viable regulatory strategy and also ensure your drug is on the best path to receiving market approval. Typically, FDA meetings will only last one hour, and you will only have one chance to get it right, so it’s vital they run smoothly so that you meet your objectives. PharmaLex US expert Mark Lane has laid out a clear step-by-step guide to meeting with the FDA to help you get the
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The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team is available to provide support as required. Our team members’ experience includes regulators, notified bodies, and industry and cover a wide range of products.
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The Technical Helpdesk is a service solution that provides your team with quick and easy access to the breadth and depth of expertise of our Consultant team giving you the confidence that an SME is available to respond to your GxP queries as they arise, without having to go through the proposal/procurement process for individual/smaller queries
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A model is a simplified image of reality that describes the relationship between factors (events and consequences) that are important to a decision. The aim of modelling is to make a particular part or feature of the world easier to: Understand, Define, Quantify, Visualize and Simulate
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COVID-19 represents an unprecedented challenge for life science companies seeking to maintain the continuity of pharmaceutical operations and product supply. Even before COVID-19, PharmaLex had developed and implemented a step-wise and risk-based methodology to deliver virtual audits.