Project Management
Single Use Design Project Management
Single Use Design can be extremely costly and can mpact organizations in a variety of ways. Let us provide lessons learned from our experience to met your timelines within budget.
Commissioning, Qualification, and Validation
Let us manage the complex needs of your equipment and validation lifecycle from Installation through Performance qualification. Our SMEs have and experience in delivery across all aspects from protocol creation, execution through approval of validation final reports.
Manufacturing SOPs and Master Batch Record Generation
Operation Readiness cannot be met without creation of the documents that serve as the backbone for process instruction and regulatory compliance. Let us help you mange the draft, review, and approval of your critical documents.
Quality System Record Management
Do you have a backlog of deviation, CAPA, and CCRs. Our SMEs have years of experience managing quality system records with Veeva, Trackwise, SAP. Let us help you meet your quality metric KPIs.