Services
Add people to your team, or hand us the whole project.
Take one service or the full lifecycle, from the first request to handoff. Either way, FDA compliance is built into the work from the start.
01
Employment Augmentation: Life Sciences IT and Compliance Talent
Need skilled people now, not after a long search? We place experienced program managers, project managers, business analysts, validation leads, developers and system administrators into your team. They know GxP and FDA expectations, so they contribute from the first week. Part-time or full-time, short or long term.
Interim or fractional IT leadership
Program and project managers
Business analysts
Validation (CSV) leads and testers
Developers and system administrators
Data, integration and reporting specialists
Contract or contract-to-hire placements
02
End-to-End Work Management: From Intake to Implementation
Most project delays happen before the build starts: requests sit in inboxes, priorities are unclear and approvals stall. We manage the whole life of the work, from one front door for requests through prioritization, approval, project management and a clean go-live. You always know what is in the queue, what is approved and where every project stands.
Demand intake and triage
Business case, sizing and prioritization
Governance and approvals, including change control
Capacity and resource planning
Program and project management with status reporting
Vendor selection and management
Implementation, go-live and hypercare
Handoff to operations
03
FDA Compliance Across All GxP Areas
Compliance built in, not bolted on. Every system we deliver meets FDA expectations across clinical, laboratory, manufacturing, quality and safety work, for drugs, biologics and medical devices, plus SOX where finance is involved. We take a risk-based approach, so effort goes where the risk is, and leave you with documentation an inspector can follow from start to finish.
Validation plans and strategy
CSV SOP gap assessments and SOP authoring
GxP and SOX risk assessments
Requirements and traceability
IQ, OQ and PQ protocols with executed evidence
Part 11 and Annex 11 assessments
Vendor qualification
Inspection readiness and periodic review
04
Hub: Intake-to-Delivery Software
See all of your work in one place, from the first request to the final deliverable. Hub gives teams a single intake portal, routes each request through review and approval, tracks team capacity and follows approved work through project delivery with status updates and dashboards. Built for GxP and SOX environments. Available as a licensed product or as part of a managed engagement.
Intake portal and standard request forms
Triage with GxP and SOX impact classification
Approval workflows
Capacity and resource planning
Project tracking with status updates
Dashboards and portfolio reporting
Setup, configuration, training and support
How a project runs
Most projects take six to eight months.
The exact length depends on how much validation the work needs. Every project moves through the same seven phases, so you always know where things stand.
01
Intake and discovery
02
Business case and GxP/SOX impact assessment
03
Approvals
04
Planning and design
05
Build, configure and validate
06
Go-live and hypercare
07
Handoff to operations
Scope
Take one service, or the full lifecycle.
A typical engagement can include any of these.
Skilled staff placed into your team
Intake, prioritization and approvals
Program and project management
Implementation and integration oversight
Validation and FDA compliance documentation
Training, go-live and handoff
Optional: Hub, our intake-to-delivery software
Systems we work with
Quality
Veeva Vault Quality (QMS, QualityDocs, Training)
Regulatory and clinical
Veeva Vault RIM, Veeva Vault Clinical, Veeva Study Training
Safety
Pharmacovigilance (PV) systems
Biostatistics
SAS servers and environments
ERP and procurement
Oracle NetSuite, Coupa, Workato
Contracts
Ironclad and other CLM systems
Microsoft
Microsoft 365, SharePoint, Power Apps, Power Automate, Power BI
Making a difference is a conversation away.
Have a system in mind? Tell us which one and when you need it live.