Marketing Authorisation Activities

High-quality, technically accomplished, well-considered and comprehensive regulatory submissions are a central factor in achieving successful regulatory approvals in a timely manner.

Technical CMC lies at the very heart of G&L’s offering, from a strategic and operational perspective along with extensive clinical, non-clinical and medical writing expertise. We provide a full suite of regulatory services to fulfil your licensing needs, including:

• Authoring of MAA, NDA, BLA, ANDA submissions
• Full procedure support for US and EU application procedures (National, MRP, DCP, CP)
• Module 1 preparation
• Module 2 Quality Overall Summary, Non-Clinical and Clinical Overview and Summaries
• Module 3 Quality
• Modules 4–5 Non-Clinical and Clinical
• Artwork and Labelling (including Summary of Product Characteristics (SmPC), Company Core Data Sheets (CCDS), Product Information Leaflets (PIL) etc.)
• Support of pre-submission meetings
• Local regulatory intelligence and support
• Response to Agency questions
• Medical Writing

G&L’s technical teams support all types of medicinal products and therapeutic areas, involving small molecules, biologicals, biosimilars, ATMPs, cell therapy and gene therapy.

“G&L staff have been wonderful in providing information in a very timely fashion and guiding us on the MAA pre-submission meeting request as well as the SmPC. They are always exceptional. Thank you so much!  We are delighted with the support provided by G&L.”

Global Biopharmaceutical company.