We work as part of your team and are fully with you on your regulatory journey , helping to navigate the complex and ever-evolving global regulatory and market access environments, pre-empting and managing the common misunderstandings that can cause you unexpected costs and delays.
Blog series: Maintaining Regulatory Momentum in the Covid-19 era: It’s been a difficult year for many biopharma companies and perhaps even more so for clinical research organisations, with Covid-19 forcing the postponement or even cancellation of many if not most clinical trials. It is however important to keep a finger on the pulse of the […]
Blog series: Maintaining Regulatory Momentum in the Covid-19 era: The global disruption caused by the pandemic meant regulatory plans for 2020 needed to be delayed to give the life sciences industry and authorities breathing room. However, it is important to keep up to date with imminent regulatory changes that will impact the industry. In my […]
Blog series: Maintaining Regulatory Momentum in the Covid-19 era: In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no […]