MHRA announces a new notification scheme for low risk clinical trials
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EMA considerations on the use of AI in the medicinal product lifecycle.
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
This article provides an overview of PRIME, Breakthrough Therapy and Fast Track regulatory procedures intended to optimise the development of medicines that target an unmet medical need.
Regulatory Affairs Expert Tony Mitchell co-authors a case study for a new IBS Drug This is case study for a joint project S-cubed worked on for a new drug for IBS – PharmaVentures was the lead company and they were providing market valuation expertise, Apex Healthcare...