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.

From the 13th - 16th June, our Director Paul Cronin, Chief Financial Officer Charles Camp CGMA and Business Development Manager Stuart Hunter returned to Scendea’s largest event of the year, BIO 2022.

Getting a new drug to the patient involves numerous stakeholders that are part of a multi-faceted regulatory framework. This framework has evolved over time and proceeds from drug discovery to development to regulatory evaluation.

The 2022 Scendea Getaway was a fun-filled weekend spent enjoying time together as a team, learning about our new members and stepping out of our comfort zones.

Drug-device combinations (DDCs) are products that include both a medical device and medicinal product constituent part. There are two main types of combination products: Integral and Co-packaged.

From 31 January 2022 CTA submissions under the Regulation can start; at this point Sponsors have the option of filing under the new the Regulation or the existing Clinical Trial Directive (‘the Directive’).