Validation, quality, and regulatory services for life sciences companies — and full-stack IT services for organizations in every industry.
Life Sciences
Life Sciences Services
V&V
Validation & Verification
Service Area
Validation & Verification Services
Validation and verification services are critical in the pharmaceutical, biotechnology, and medical device industries to ensure that products and processes meet regulatory requirements, are safe, and are effective.
Computer System Validation (CSV) per 21 CFR Part 11 and GAMP 5
ALCOA++ / Data Integrity Assessments and Remediations
CSV Assessments and Remediation Programs
Process Validation (IQ, OQ, PQ) Protocol Development
Equipment Qualification and Calibration
Cleaning Validation and Method Validation
Test Script Development and Execution
Validation Master Planning
Service Area
Quality & Risk Management
We are committed to helping businesses of all sizes achieve their quality and risk management goals. Our team works alongside your organization to build robust quality systems and implement strategies to improve quality outcomes.
Quality Management System (QMS) Development & Optimization
Risk Assessments (ICH Q9, FMEA, HACCP)
CAPA Management and Effectiveness Monitoring
Deviation and Non-Conformance Investigation
Audit Readiness Preparation (FDA, EU, ISO)
Supplier Quality Management Programs
Change Control System Design
GxP Compliance Strategy and Gap Assessments
QRM
Quality & Risk
MedDev
Medical Devices
Service Area
Medical Device Services
Comprehensive engineering services for medical device development and manufacturing. We support manufacturers through design, development, regulatory submission, and post-market activities.
Design Controls and Design History File (DHF) Management
IEC 62304 Software Lifecycle Compliance
FDA 510(k) and PMA Submission Support
EU MDR / IVDR Compliance
Risk Management per ISO 14971
Post-Market Surveillance and Vigilance
Usability Engineering (IEC 62366)
Biocompatibility Assessment Support
Service Area
Automation
We help life sciences organizations streamline operations through intelligent automation — from laboratory systems to manufacturing execution, improving efficiency while maintaining full regulatory compliance.
Laboratory Automation and LIMS Implementation
Manufacturing Execution System (MES) Support
SCADA System Integration and Validation
Process Automation and Control System Design
Robotic Process Automation (RPA) for Lab Operations
Serialization and Track-and-Trace Systems
Electronic Batch Records
DCS Configuration and Qualification
AUTO
Automation
QA
Quality Assurance
Service Area
Quality Assurance
We can help across all areas of QC and laboratory on both the analytical and microbiological side — from designing a laboratory to reviewing existing quality control processes and implementing strategies to improve outcomes.
GxP Compliance Auditing and Gap Analysis
SOP Development, Review, and Harmonization
Batch Record Review and Release
Environmental Monitoring Program Management
Stability Testing Program Support
Instrument Qualification (IQ/OQ/PQ)
Analytical Method Validation and Transfer
Regulatory Inspection Preparation and Support
Information Technology
IT Services
DEV
Application Development
Service Area
Application Development
Build robust, scalable applications with enterprise-grade architecture and modern development practices. Our team understands the latest trends and innovations, enabling us to provide solutions that match the specific demands of our clients. For regulated clients, we build and integrate systems with validation deliverables included.
Custom Enterprise Application Development
Web Applications (React, Angular, Vue.js)
Mobile Apps (iOS, Android, Cross-Platform)
API Design, Development, and Integration
Legacy System Modernization and Migration
E-Commerce Platform Development
Database Design, Optimization, and Management
DevOps, CI/CD Pipeline Setup and Management
Service Area
Cloud & Application Services
Accelerate growth with scalable, secure cloud platforms. We help organizations with IT migration and upgrades, infrastructure qualification, and enterprise-grade cloud architecture. For life sciences clients, migrations are planned with qualification and 21 CFR Part 11 / EU Annex 11 controls in mind.
Cloud Migration Strategy and Execution (AWS, Azure, GCP)
Infrastructure as Code (Terraform, CloudFormation)
Containerization (Docker, Kubernetes, OpenShift)
Infrastructure Qualification for Regulated Environments
Microservices Architecture and Design
Disaster Recovery and Business Continuity Planning
Performance Monitoring and Optimization
Managed Cloud Services and Support
CLOUD
Cloud & Applications
DATA
Data & Analytics
Service Area
Data & Analytics
Turn data into actionable insights for smarter decisions. We offer comprehensive data management solutions and can manage, analyze, and interpret complex data sets using various tools and platforms. For regulated clients, we keep data pipelines ALCOA++-compliant from source to dashboard.
Big Data Processing and Engineering
Business Intelligence and Reporting
Data Warehouse Design and Optimization
ETL/ELT Pipeline Development
Real-Time Data Streaming and Analytics
Data Governance and Quality Frameworks
Statistical Analysis and SAS Programming
Data Visualization (Tableau, Power BI)
Service Area
AI & Machine Learning
Harness the power of AI and Gen AI to unlock new growth opportunities. Our AI solutions provide deep insights, predictive analytics, and automated intelligence across all business operations. For regulated clients, we add the documentation, controls, and risk assessments that validation requires.
Custom AI/ML Model Development and Training
Natural Language Processing (NLP) Solutions
Predictive Analytics and Forecasting
Computer Vision and Image Recognition
Intelligent Document Processing and Automation
Recommendation Engine Development
Data Science and Advanced Analytics
MLOps and Model Lifecycle Management
AI/ML
Artificial Intelligence
SEC
Cybersecurity
Service Area
Cybersecurity Services
Protect your digital assets with comprehensive security frameworks. We help organizations assess vulnerabilities, implement robust security architectures, and maintain compliance with industry standards. For life sciences clients, we protect GxP systems, patient data, and product data while keeping audit trails intact.
Security Assessment and Penetration Testing
Security Architecture Design and Review
Identity and Access Management (IAM)
Security Information and Event Management (SIEM)
Compliance Frameworks (SOC 2, HIPAA, NIST, ISO 27001)
Incident Response Planning and Execution
Data Loss Prevention and Encryption
Security Awareness Training Programs
Service Area
Talent Solutions
Access top-tier talent with our comprehensive staffing solutions. We specialize in providing highly skilled professionals across Java, Python, JavaScript, .NET, AWS, Azure, Docker, Kubernetes, and DevOps. We also place validation engineers, quality specialists, and regulatory professionals for pharma, biotech, and medical device teams.
