Our Services
S Cubed Validation Consulting, LLC offers comprehensive validation consulting services spanning multiple regulated industries including Biologics, Tissues, Vaccines, Medical Devices, and consumer products. The firm specializes in creating and overseeing validation programs for manufacturing facilities, including equipment commissioning and qualification, cleaning/sterilization/process validation, quality assurance, process development, and technical operations.
Services extend to facility buildouts with cleanroom certification to ISO standards, CIP/COP commissioning and validation, compliance remediation, and project management for site startups. The consultancy provides expertise in regulatory compliance preparation, documentation development, technical reviews, and training implementation.
Validation
Protocol and Report Generation
Validation Master Plans
Validation Project Plans
Microbial and Analytical Method Strategy Support
Grouping Strategies
Recovery Studies
MACO/MSC Calculation using HBEL
Hold Time Development and Validation
Standard Operating Procedure Creation
Execution Support, Tracking, and Planning
Worst-case Product Assessments
Equipment commissioning and qualification
Cleanroom Certification
Sterilization Validation (SIP / Autoclaves)
Cleaning Validation
Process Performance Qualification (PPQ)
Compliance
PAI/Inspection Readiness
Gap Assessments
Remediation
Risk Assessments
Deviation / Excursion Authoring and Review
CAPA
Worst-case Product Assessments
Regulatory Audit Support
Regulatory Filing Authoring
General
Project and Program Management
Vendor Bid Review and Management
Training
Staff Mentoring