Empowering Life Sciences Innovation
Through Optimal IT Solutions
Our Clients
CSV & CSA UNIVERSITY AI IMPLEMENTATION & VALIDATION
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December 10-12, 2024 | Arlington, Virginia Crystal City Marriott
Our Values Are The Foundation Of Our Work
Partnership
We believe in building strong, collaborative relationships with our clients, working closely to understand their unique needs and deliver solutions that drive mutual success.
Results Oriented
Our focus is on achieving tangible outcomes that matter. We’re committed to delivering measurable results that align with your business goals and create lasting impact.
Effectiveness
Precision and purpose define our approach. We aim to provide solutions that address core challenges directly, ensuring effectiveness in every project we undertake.
Efficiency
Maximizing resources and time is our priority. We streamline processes and leverage expertise to deliver high-quality solutions swiftly and cost-effectively.
Where Vision Meets Execution: Our Partnership Path
Connect
We build enduring partnerships through open dialogue and deep understanding. Your unique challenges become our focus as we lay the foundation for lasting success.
Engage
As your dedicated partner, we immerse ourselves in your organization's vision and challenges. This intimate understanding enables us to develop tailored solutions that drive measurable success.
Collaborate
Innovation thrives when expertise converges. We combine our deep life sciences and technical mastery with your business insights to create transformative solutions that accelerate growth.
Deliver
We exceed expectations by implementing precise, scalable solutions for your most pressing challenges. Your success becomes our shared achievement, strengthening our ongoing partnership.
CASE STUDIES
Streamlined LIMS Implementation for a Growing Biotech Company
Our client, a large pharmaceutical company, was transitioning their global LIMS system from one vendor to another.
Streamlining Global LIMS Reporting for a Large Pharmaceutical Company
Our client, a large pharmaceutical company, was transitioning their global LIMS system from one vendor to another.
Ensuring Regulatory Compliance for a Custom EDC Application
Our client, an ophthalmologic biotech company, required a custom Electronic Data Capture (EDC) application built by a third-party provider.
Reviving a Dormant Stability LIMS System for Efficient Workflows
Our client had implemented a Stability LIMS solution several years ago but never configured or validated it for their intended purposes.
Rapid QC Lab Qualification for Gene Therapy Company
A newly-acquired gene therapy company needed to quickly release a therapy for a rare disease, requiring the qualification of a QC lab within a ….
Our Services
Quality Management
Effective quality management is the cornerstone of compliance in the life sciences industry. Our services ensure that your organization meets regulatory standards while enhancing operational efficiency. We provide end-to-end support in developing and improving Standard Operating Procedures (SOPs), conducting audits, and implementing advanced quality management systems that keep your processes compliant and streamlined.
- Quality Process Design & Implementation
- SOP Development
- eQMS Implementation
- Audit Support
CSA/CSV
Computer System Assurance/Validation (CSA/CSV)
In today’s life sciences landscape, system assurance and validation are critical for compliance and operational integrity.
- Computer System Assurance
- Infrastructure Qualification
- Lab Instrument Qualification
- SaaS Continuous Compliance
IT Compliance
IT Compliance
Robust IT compliance is essential for protecting your business and maintaining regulatory
adherence.
- IT Policies
- SOX Compliance
- NIST Compliance
- Disaster Recovery / Business Continuity Planning
LIMS, ELN, CDS
LIMS, ELN, and CDS Services
The right digital tools are essential for managing data, processes, and compliance in
laboratories.
- Business Process Analysis
- Vendor Selection
- Custom Development
- Master Data Development
GxP Labs
GxP Labs
Setting up a compliant, reliable, and secure lab environment is essential for GxP-regulated
industries.
- Network Buildout
- Network Segmentation
- Network Qualification
- Instrument Setup, Configuration, and Qualification
DELIVERY MODELS
Our Managed Services model allows you to focus on your core business while we take care of your specific project or operational needs. We provide end-to-end management, from planning and execution to ongoing support, ensuring seamless integration with your existing processes and delivering results that meet or exceed your expectations
With our Staff Augmentation model, we provide you with skilled professionals who complement your in-house team, helping you address short-term or long-term resourcing needs. Our experts bring deep industry knowledge and experience, ensuring you have the right talent to achieve your project goals.
Our Global Team delivery model consists of onshore, offshore, and nearshore consultants, providing you with a wide range of options to address your specific needs. This approach enables us to offer cost-effective solutions while maintaining high-quality standards. Our diverse team of experts works closely with your in-house staff, ensuring seamless collaboration and communication throughout the project.
TESTIMONIALS
Gudrun Finn
Sr. IT Executive, Biotech
Kathy Zagaroli
Senior Director, Quality Control, Kiniksa Pharmaceuticals
Franky Choi
Head of PMO, Large Biotech Firm
Kent Johnson
Associate Director, Clinical Operations, Arcus Biosciences
Igor Komm
Director, System Qualification and Validation, Kiniksa Pharmaceuticals
Anthony Grilli
CEO Focus Labs
CONTACT US & FAQ
Getting started is easy! Contact us to discuss your needs, and we’ll provide tailored solutions to help you achieve compliance and operational excellence.
