Regulatory Affairs

Service Description

• Marketing authorisation applications: National / MRP / DCP / CP Procedure • Regulatory Affairs support across the product lifecycle (variations, renewals, annual reports) management • CTD Conversions (content and format) • Publishing support – all submission types and format, and reports • labelling and patient information leaflets • GAP Analysis • Regulatory Affairs and CMC strategic guidance • Depending on your need, we can work with local affiliates and agents, to provide you with local submission support and case management • Regulatory services cost-efficiently outsourced

Contact Details