Cambridge Regulatory Services
Mike James is a highly experienced regulatory professional with a background in pharmaceutical chemistry. Mike has held various senior positions in companies such as Cambridge Regulatory Services, Akos Limited, and MHRA. With a PhD in Medicinal Chemistry, Mike has a strong foundation in the field and has also worked as a lecturer in pharmaceutical and medicinal chemistry at Welsh School of Pharmacy. Their expertise lies in providing strategic and practical advice to biotech clients, ensuring compliance with EU regulators, and assessing quality and clinical trial applications for marketing authorizations.
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Cambridge Regulatory Services
Cambridge Regulatory Services is a full service regulatory affairs consultancy helping pharmaceutical companies get their medicines to market faster. Help comes in many forms, • Consultancy for product development • Orphan Drug Designation Application • Clinical Trial Application - EU Wide • Regulatory strategy and due diligence/gap analysis on the dossier • Dossier preparation for Marketing Authorisation Application • User Testing on Patient Information Leaflet • Post approval and maintenance service • Pharmacovigilance • Medical information • In-Licencing/Out-Licencing Benefits of working with CambReg Fixed price option available Many types of projects lend themselves to a fixed price quotation. This is a popular choice for clients who need to set a budget and are able to work to an agreed timetable for data provision and document approval Service Continuity Clients tell us that what they really appreciate is the continuity of the service that we offer. Where possible, we make sure that your designated project team leader stays with you throughout the lifetime of your project. We will work with you on a one-to-one basis to monitor progress and to ensure that agreed milestones and deadlines are met and that your project reaches a timely and successful conclusion. Project Progress Reports You choose, at the beginning of your project, when and how you wish to be informed of progress – from a phone call daily to a monthly written report – what ever suits you Knowledgeable and experienced team (including Ex Regulators) Our team is a mix of seasoned industrial professionals, with the skills and proven ability to advise on and manage any regulatory matter - no matter how complex, plus highly skilled administrators and enthusiastic young regulatory executives allowing CambReg to maintain its competitive edge for projects involving more routine aspects of RA e.g. DCP