Axios Clinicals
QUALITY & VALIDATION SERVICES
GXP QUALITY & VALIDATION
Being compliant and being in compliance can mean entirely different things. Our GXP Quality Services guide our clients through global regulatory changes while helping them avoid crippling fines and delays caused by non-compliance. Our support allows industry professionals and project managers to optimize their time and dedicate their resources to the clinical and manufacturing tasks necessary within the Medical Device, Pharmaceutical and Biotech Industries.
Our team of industry-leading experts is uniquely qualified to support a variety of initiatives, including:
- Project-specific quality planning
- Fully outsourced quality infrastructure engagements
- Project support through individuals and specialized teams, or as the project requires
QUALITY
Axios Clinicals offers a customized and scalable suite of services, including:
Audits
- Systems
- Documents
- Vendors
Infrastructure Support
- Quality Planning
- SOP Development
Specialized Consulting
- Response to FDA Guidances
- Gap Analyses
- Inspection Readiness
- Risk Management
VALIDATION
Axios Clinicals provides consulting and staffing services across the full lifecycle of validation. Validated systems are critical to avoid FDA 483 letters and financial penalties. Advancements in technology fuel the need for more efficient analytic systems, increasing the complex responsibilities of ensuring these systems are validated.
Whether large or small in scale, Life Sciences systems play an equal role in supporting a successful clinical trial. Collaborating with an experienced partner is critical to successful validation. Our team of experts, including our pipeline of readily available consultants, is prepared to support a wide range of validation compliance solutions and validation project staffing needs
VALIDATION SERVICES
- VERIFICATION ENGAGEMENTS
- SYSTEM-SPECIFIC OVERSIGHT
- CHANGE MANAGEMENT
- RISK AND GAP ASSESSMENTS
- PROJECT STAFFING
Software Systems Lifecycle Development
- Phsae I – IV System Assessment
- Project & SOP Management
- Risk Based SDLC Consulting
- Audit Ready SDLC Documentation
Qualification & Validation Execution
- Full GXP System Validation Lifecycle Phase Management
- GCP, GLP & GMP Qualification Oversight
- 21 CFR Part II Assessment & Compliance
Release Management
- Post Release Change Control Management
- Vendor Management
- 24/7 Technical Support Framework
CONTACT AXIOS
Axios Clinicals is committed to protecting and respecting your privacy, and we’ll only use your personal information to administer your account and to provide the products and services you requested from us.
If you need urgent support, simply call our 24 hour emergency hotline.
Your personal case manager will ensure that you receive the best possible support.
Call Now (toll free)