Life Sciences: NDA Application to the FDA

Client: Midsize Pharmaceutical Company Problem A midsize pharmaceutical company (Sponsor) was submitting their first ever NDA application to the FDA. As per their discussion at the pre-NDA meeting with the review division at the FDA, the Sponsor’s commitment was to submit clinical data sets in addition to the ISS and BIMO data sets for six… Read more »

A Softworld Life Sciences Case Study

Life Sciences Staffing & Consulting Solutions Client: Mid-sized Pharmaceuticals Company The proposed services will include installation, configuration, and qualification of the SAS system. It also covers scope related to managing and hosting of the SAS server environment. In addition to Softworld’s internal Quality Management System (QMS), our trusted IT Management Services partner has a robust… Read more »