How can JensonR+ help you? We can support your devices & borderline products project and advise you every step of the way by finding the best conformity assessment route for your product. We can generate relevant data to populate your technical file, advise on labelling and essential information, and create a [...]
How can JensonR+ help you? Within the European Union all holders of Marketing Authorisation are obliged to maintain a Scientific Service to answer and collate medical and scientific enquiries from healthcare professionals as well as members of the public. Our experienced team can provide a dedicated, English-language medical information service [...]
How can JensonR+ help you? All medicinal products need to obtain a marketing authorisation (MA) before they can be placed on the market. The MA certifies the product meets the required standards of safety, quality and efficacy. There are four routes to gaining a MA in the EU: Centralised [...]
How can JensonR+ help you? We offer expertise in the development of API, medicinal products, medical devices, foods, traditional herbal medicines, cosmetics and borderlines across multiple presentations and dosage forms. We can support any part of your process and we can manage your entire development. We would like to talk to you, and we will [...]
How can JensonR+ help you? The aim of pharmacovigilanceis the safer and more effective use of medicines for everyone. It involves all activities that relate to noticing, assessing, understanding, managing and preventing adverse effects of medicines for individuals and populations. From the moment a marketing authorisation is applied for and [...]
How can JensonR+ help you? A sound quality management system (QMS) is a legislative GxP requirement and enhances organisation through an iterative process of continuous improvement. We provide European Union batch release and certification by a Qualified Person, in addition to importation and retesting and can help you manage your [...]
How can JensonR+ help you? After the expenditure and effort of product development, it is essential to ensure that you get the best out of your investment. The field of regulatory affairs encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a [...]
