Publishing and Submission

G&L has a wealth of experience in compiling, authoring and publishing regulatory submissions across most markets, as well as liaising with, and submitting to, all major regulatory agencies around the globe.

We have a strong reputation for delivering robust first-time-right regulatory submissions in an agile and timely manner.  We support the submission of all types of medicinal products and therapeutic areas, involving small molecules, biologicals, biosimilars, ATMPs, cell therapy and gene therapy. Our comprehensive suite of Publishing and Submission services includes:

• eCTD Publishing – all major English-speaking markets (US, EU and ROW)
• Other electronic submissions
• Submission Management – project and timeline management
• Submission Readiness
• Local/Portal Submissions
• Regulatory Data Management
• CTD Dossier conversion and preparation of eCTD baselines

Our publishing and submission teams are equally accomplished at utilising either existing client software systems or G&L’s fully- validated, in-house eCTD publishing software suite, Lorenz docuBridge.