Our client a global pharmaceutical and biotechnology company specialising in the research, development and marketing of medicines and vaccines for immunology, oncology, cardiology endocrinology and neurology, asked BlueReg to publish and submit a Marketing Authorisation Holder transfer to ANSM for…
The promotion of medicinal products is governed by advertising laws and regulations in the European Union (EU). In particular, the Directive 2001/83/EC ‘of the European parliament and of the Council of 6 November 2001 on the Community code relating to…
BlueReg is an international pharma consultancy offering strategic regulatory advice and hands-on outsourcing solutions to life sciences companies through a multitude of services from Product development to life cycle management, Early Access Programs and more. We are experienced in…
The regulatory affairs process is a critical component of the safe development, registration and commercialization of pharmaceuticals. There are numerous factors to consider when developing a strategy for regulatory affairs, including information management, scientific writing, clinical trial design and conduct,…
As a pharmaceutical company, you want to make sure that your launch strategy in Europe is as successful as possible. It's important to be aware of the regulatory affairs involved and how they can impact your product launches. In addition,…