The Consultants in our Global Regulatory Services team have extensive European Medicines Agency (EMA), Food and Drug Administration (FDA) and national Regulatory Agency experience. They can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers.
Our experts can help you understand new and existing guidance to ensure the medicinal product meets all regulatory guidelines; and support with product development strategy from early phase to the marketing authorisation submission.
BlueReg can also define effective regulatory strategies, aligned with the company’s and regulatory requirements, in order to facilitate post approval activities. Submissions can be prepared, or reviewed for deficiencies, along with a thorough gap analysis and risk assessment prior to submission to ensure that any questions that may arise from Health Authorities are anticipated and can be prepared for responses.
BlueReg can also help with Quality Control and publishing of regulatory submissions, and preparation for Agency meetings.
EMA GUIDANCE – COVID-19
Given the support given to our clients in interactions with health authorities all around the...
News - 23 April 2020
Nitrosamine impurities – are you ready to fulfil your legal obligations as a MAH by March 26th, 2020?
During the summer 2018, authorities become aware of the presence of some nitrosamines in API...
News - 12 February 2020