Dossier Compilation and Management
Whether provided as part of overall project management or on a stand-alone basis, Regxia will advise on a full range of regulatory services to assist with your clinical, marketing and post-approval submissions. Regxia has a successful track record in negotiating with Regulatory Agencies worldwide. We specialize in submission types from the beginning of product development through to post-approval; we are with you the entire way. Our services include but are not limited to eCTD compilation, adaptation of eCTD for new markets, and review and advisement on CMC, nonclinical and clinical dossiers.