Regulatory Operations

SciLucent provides services to facilitate the submission of regulatory documentation in electronic Common Technical Document (eCTD) format. We assist in identifying and developing the necessary components for every type of regulatory submission. We provide eCTD templates to our clients at no additional cost. We ensure that the files we provide to regulatory agencies are complete and formatted for acceptance by the Agency. We are also available to provide support for paper submissions as requested by a regulatory agency.

As of May 5, 2018, all commercial INDs, NDAs, BLAs, and ANDAs, amendments, and supplements are prepared in eCTD format and electronically submitted to FDA. The number and type of regulatory submissions being accepted by FDA in electronic format continues to grow and is expected to replace other types of submission. SciLucent uses commercially available software to publish submissions according to relevant guidances and specifications. To ensure that submissions are free of technical issues, they are validated prior to transfer to FDA. Since 2014, SciLucent has successfully prepared and transferred over 750 electronic submissions to FDA. We ensure that all submissions are appropriately acknowledged.