The CTA team at Diamond Pharma Services is integrated into the Regulatory Development Department. The team has extensive experience in CTA activities for a wide range of product types.
- New chemical entities
- Advanced therapy medicinal products (gene & cell therapy). Diamond have expertise advising and supporting:
- CTAs submitted to many EU national competent authorities
- EU wide competent ethics committee requirements
- Voluntary Harmonisation Procedures (VHP)
- Genetically Modified Organism (GMO) applications
- Substantial amendments, end of trial, etc.
The team can offer both outsourced CTA department coverage as well as specialist ad hoc advice to the Regulatory and Clinical teams within Sponsor companies.
Diamond can also provide an EU regulatory team to help non-EU Sponsors to coordinate the interface between the Sponsor’s Regulatory/Clinical Teams and their large CROs managing clinical operations. In this model Diamond has demonstrated process improvements for US Sponsors by providing a team of EU specialists to integrate with the Sponsor’s internal US specialists.