DDReg Pharma- Consulting in regulatory affairs and drug safety

Introduction & overview The regulatory landscape, including pharma regulatory affairs , has faced major revolution and transformation by adopting the eCTD format across the globe. Electronic submissions are driving efficient product authorizations and approvals for pharmaceutical organizations to stay ahead of the market. Undoubtedly, these benefits of eCTD are enormous- particularly the fact that the eCTD format reduces the time and resources needed for regulatory submissions. Furthermore, it provides enhance management and tracking of the necessary regulatory information while maintaining compliance. But the transition from paper-based submissions to NeeS to eCTD is not as straightforward as it seems as it is associated with many challenges regarding added cost, resources, and time.  Transition to the eCTD One of the main challenges that regulatory professionals face when transitioning to the eCTD is the time and resource it takes. For example, organizations would need to inves