Drug substance Regulatory Affairs and Quality Assurance
- On your behalf, Seqens will file the Active Substance Master File (ASMF), Certificate of Suitability (CEP), Drug Master File (DMF) and other regulatory documents containing relevant details of the manufacturing process to enable the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other international pharmaceutical regulatory agencies to review process information in support of third-party drug product marketing applications. Upon request, we will also provide a letter of authorization/access to will allow such agencies to review the DMF.
- Seqens has an in-house Regulatory Affairs team that includes 30 Quality Assurance staff members handling more than 80 active DMFs. Additionally, in countries where the process patent remains in force, our in-house IP team can also design non-infringing patent processes that allows you to launch a new formulation faster. Your formulations will be cost-competitive, because Seqens has deep experience with incorporating original technologies and working with final chemical microarrays.