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
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.”
“Thank you so much for your contribution in supporting data verification for the vaccine MAA. The timelines were very tight and the source documents were available on a rolling basis. Furthermore there were many complexities to the submission and the source documents. I appreciate your flexibility, willingness to put in the extra hours to meet the deadlines, and your thorough review and helpful comments in the process. Thank you for demonstrating excellence, and for supporting this important project!”
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