The COVID-19 pandemic has led to unprecedented public investments, at-risk investment in (clinical) development and manufacturing, and the streamlining of regulatory processes, resulting in rapid, focussed, and collaborative development of COVID-19 vaccines and acceptability of new vaccine platforms.

We are thrilled to announce the release of our new whitepaper, in collaboration with FGK, "Clinical Trial Regulation: A New Chapter for EU Clinical Trials", authored by Senior Consultant, Amy Cooke, Principal Consultant, Dr Maria Beatrice Panico, and Director of Regulatory Affairs at FGK, Dr Uwe Kramer.

Pharmaceutical research and development is costly, lengthy and risky. It takes years and significant financial investment to get a drug from concept to approval. However, even with such enormous effort and expense, most drugs never make it to the market.

Scendea were delighted to attend the 10th annual MIBio conference, which brought together experts in the field of biologics formulations. Since the development of mRNA vaccines during the COVID pandemic, significant advances have been made in formulation approaches to ensure the stability, safety, and efficacy of novel products.

Over September and October, our Director, Paul Cronin, and Senior Business Development Manager, Stuart Hunter, have travelled to pharmaceutical and biotech hotspots in Canada, the US and Europe, to attend leading life science conferences, networking events, and meetings with our valued clients…

The focus of the TOPRA annual symposium, hosted this year in Vienna, was Regulatory Science – leading the way to the future. Accordingly, the sessions covered the relevance of innovative clinical trials, expedited procedures, digital health, real-world evidence and data.

At Scendea, we believe in creating a collaborative environment for the team. By immersing ourselves in team building activities and company events, we believe we are forging the foundations to a successful and collaborative working environment.

On 1 January 2021, EU pharmaceutical law ceased to be effective in Great Britain (GB), i.e., England, Wales and Scotland. Medicines and medical devices have since been regulated in GB under national law by the MHRA.

This July, the Scendea team made their way to Newmarket for an exciting day of horse racing, housed in the beautiful setting of the Champions Lawn.