Quality, Validation, Regulatory, Clinical.
Do you have the experts you need? Expert quality, compliance, and regulatory consulting for life-science companies globally.
Validation Associates offers a right-sized approach by leveraging appropriate technology, providing key personnel, and utilizing our extensive knowledge and framework to deliver solutions quickly and in a compliant manner.
We have served pharmaceutical, biotech, and medical-device companies with validation and staffing services - including validation strategies, IQ/OQ/PQ scripts, test documentation, traceability matrices, and summary reports.
- 01Project Planning
- 02Requirements Definition
- 03Solution Design
- 04Solution Configuration & Development
- 05Quality Assurance & Validation
Validation
Strategy, master planning, and protocol execution across computer systems, processes, equipment, and facilities.
Discuss this service- +Consultation
- +Staff augmentation
- +Computer system validation
- +Process validation
- +Equipment qualification
- +Cleaning validation
- +Enterprise application compliance solutions
- +IT infrastructure qualification
- +Facility / utility commissioning & qualification
- +Analytical instrument & equipment validation
- +Strategy & program development
- +Assessments
- +Master planning
- +Protocol development & execution
- +Software / 21 CFR Part 11
- +Equipment
- +Program outsourcing
Compliance & Quality Systems
Regulatory gap analysis, GMP/QSR support, and FDA inspection readiness for sites of every size.
Discuss this service- +Consultation
- +Regulatory gap analysis
- +Program development
- +GMP / QSR
- +FDA readiness audit
- +Planning, implementation & training
Clinical Study Compliance
GLP and GCP assessments, sponsor and monitor support, and clinical-data oversight across the trial lifecycle.
Discuss this service- +GLP assessments
- +GCP compliance assessments
- +Clinical investigator support
- +Sponsor support
- +Monitor support
- +Central study file
- +Database & data management
- +Institutional review board
Technical Services
Validation projects, technical staffing, risk assessment, and end-to-end execution for regulated systems.
Discuss this service- +Validation projects and/or staffing
- +Clinical systems risk assessment
- +Validation planning
- +Vendor auditing
- +Risk assessment & mitigation
- +User requirements gathering & documentation
- +Validation project management
- +System design documentation (FRS, DS)
- +Qualification protocols (IQ, OQ, PQ)
- +Validation reporting
- +Traceability matrices
- +SOP development & review
- +Validation gap analysis & remediation
- +21 CFR Part 11
- +Test script creation & execution
- +Quality & system audits
- +Training & education programs
- +HIPAA, HL7, Sarbanes-Oxley
Healthcare
A strategic healthcare staffing partner focused on measurable outcomes - high-performing teams, reduced hiring risk, and long-term retention.
Our solutions are designed to not only fill positions but also improve workforce stability, reduce hiring risks, and enhance long-term retention.
Discuss this service- +Faster access to highly qualified and compliant healthcare professionals
- +Scalable hiring models across MSP, VMS, and direct clients
- +Improved hiring efficiency through structured processes
- +Enhanced candidate engagement and retention strategies
Staffing Solutions
Contract, contract-to-hire, direct-hire, and small-project consulting for healthcare and life sciences - backed by 40+ years of combined recruiting expertise.
We specialize in contract staffing, contract-to-hire, direct-hire search, and small-project consulting services for the healthcare and life-sciences industry. Our team has over 40 years of combined recruiting experience and unparalleled expertise in sourcing Quality, Scientific, Validation, Clinical, Regulatory, Compliance, and healthcare experts nationwide.
Discuss this service- +Contract staffing
- +Contract-to-hire
- +Direct-hire search
- +Small-project consulting
- +Fractional executives
- +Project management contractors
- +Medical writers
- +Bioinformatics experts
- +Quality & scientific specialists
- +Validation & clinical specialists
- +Regulatory & compliance specialists
- +Healthcare specialists - nationwide