Whitesand NetWorks has extensive experience supporting the special needs of pharmaceutical clients. Led by Jon Vielhaber and his extensive background in the industry, Whitesand currently supports several pharmaceutical companies and clinical research organizations (CROs). Some of the activities that Whitesand has been instrumental in completing include:
Submission of electronic New Drug Applications (NDAs)
Scanning, PDF Conversion, and printing of paper NDA submissions
Setup and validation of GMP/GLP labs
Setup of several administrative networks for pharmaceutical companies and CROs
Development and implementation of computer related SOPs
Providing training on computer related SOPs
Development and execution of various qualification and validation protocols
Involvement in various computer related Quality Assurance / Quality Control (QA/QC) activities
Participation in audits and preparation of audit responses