Clinical Trial Applications (CTAs)

We have a dedicated Clinical Trial Application (CTA) team within our regulatory development group. This team has orchestrated and submitted clinical trial applications (CTAs) across many European countries for a wide range of product types.

Our team of experts has experience in the UK, The Netherlands, Germany, France, Spain, and Belgium for trials related to small molecules, biologics, and cell and gene therapies. We have managed the clinical trial applications for a diverse range of clients, including biotech companies running a single clinical trial through to larger pharmaceutical companies with more than 30 new applications per year and a large volume of substantial amendments.

Companies developing cell and gene therapies (also referred to advanced therapy medicinal products or ATMPs) face additional challenges, both operational and technical, when designing and executing regulatory strategies for these products

In particular, products classified as genetically modified organisms (GMO) will be subjected to a GMO permit application. This is an additional permit that must be obtained prior to the initiation of a clinical trial.

As with clinical trial applications, the GMO application is also submitted to each individual EU member state in which the clinical trial is to be conducted. The processes for obtaining the GMO permit can vary significantly between member states.
Given our leading position in advising cell and gene therapy clients, our team of experts is very familiar with the latest expectations for these clinical trial applications and also for ancillary procedures such as GMO applications and the authoring of related technical documents such as Environmental Risk Assessments.

We provide comprehensive support to our clients’ clinical development and regulatory teams and we specialize in helping US clients launching their programs in Europe. We lead agency interactions through the application process, negotiate pragmatic solutions towards approval, and support regulatory compliance programs throughout the clinical trial. Our team can provide both outsourced CTA department coverage as well as specialist ad hoc advice to the regulatory and clinical teams within client’s organization.


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