Personalized services

Work with us! We have experience preparing for successful NDA, BLA, and 510K filings, often for therapeutics and devices with no predicate, always by due date.  

 Validation Services
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Equipment Lifecycle Documentation:
Validation Plan
​User Requirement Specification
Risk Assessment
Functional Specification / Design Specification
Factory Acceptance Test / Site Acceptance Test
Turnover Package
​Validation Protocol
Trace Matrix
Summary Report
Periodic Review

Cleaning Validation:
Maximum Carryover Calculation
Equipment equivalence and worst-case assessments
Clean Hold / Dirty Hold Time assessments

Process Validation:
Failure Modes Effects and Analysis
Process Characterization Studies
Process Performance protocols and reports
​Regulatory report authoring with data verification

QC Method Qualification:
LOD, LOQ, and linearity assay - for diagnostics and production

Deviation Investigation

Our investigators routinely assemble the technical teams required to determine underlying root causes.  With all contributing causes identified, we document management agreement with Corrective and Preventive Actions that are effective at solving the problem without further trending.

Project Management - Facilities, Production and QC

Initiation
Planning and Budgeting approval
Resource Loading
Execution
Monitoring and Control
Closure