•  

Navigation

  • About Us
    • Why Us
    • Testimonials
  • Services
  • Resources
    • White Pages
    • Case Studies
    • Useful Links
  • Clients
  • Partners
  • Careers
    • Current Openings
  • Contact

Testimonials

View our Services

Validation Associate's strong reputation is built on a commitment to superior service and a focused, strategic approach to providing quality solutions to our life sciences clients:


Validation Associates consistently met our needs and their resources often exceeded expectations. The personal attention of their dedicated staff really makes the difference.
I feel confident in saying that we will continue to use Validation Associates LLC as our staffing partner

Manager,

Big Pharma, NJ

Validation Associates has always bent over backwards to meet the needs of my staffing requirements, no matter how different or complex they may be. They are definitely a preferred vendor for my needs.

Hiring Manager

Midsize Biotech Company, Boston

Validation Associates has consistently delivered superior results in staffing and their full service approach is what working with a true business partner really means. Their unique understanding of people, along with their solid grasp of technical matters, makes them outstandingly qualified to find the right professionals. Working with Validation Associates is truly a professional, productive and results-driven experience.

V.P.

USDM, CA

Validation Associates has consistently met the needs of my organization and often exceeds my expectations with the people they provide. They have proven the ability to learn my management style and teams overall skill set needs. Although forming teams can be challenging, Validation Associates reduces a lot of the stress with finding talented professionals. For the past 3 years they truly have partnered with our organization. I can confidently rely on Validation Associates to match my organization's needs as we have grown and evolved.

Validation Manager

for pharmaceutical company

Their deep understanding of the global regulatory landscape and far-reaching network ensures best-in-class regulatory strategy and management solutions. Their unique understanding of people, along with their solid grasp of technical matters, makes them outstandingly qualified to find the right professionals. Working with Validation Associates is truly a professional, productive and results-driven experience.

HR Director

KBI Pharma

For more than five years now I have enjoyed a strong working relationship with Validation Associates Throughout the past eight years Validation Associates has provided our company with qualified dependable employees that have contributed to our success as an organization. Their staff is highly energetic, professional, and has demonstrated a "whatever it takes" attitude in meeting our employment needs. Together we have created a partnership that will continue to prosper and grow into the future."

Recruiting Manager

RCM

Validation Associates has consistently met the needs of my organization and often exceeds my expectations with the people they provide. They have proven the ability to learn my management style and teams overall skill set needs. Although forming teams can be challenging, Validation Associates reduces a lot of the stress with finding talented professionals. For the past 3 years they truly have partnered with our organization. I can confidently rely on Validation Associates to match my organization's needs as we have grown and evolved.

Vice President, Terumo

Cardiovascular Systems, MI

Regulatory Affairs and Quality Offerings

Validation

  • Consultation
  • Staff Augmentation
  • Computer System Validation
  • Process Validation
  • Equipment Qualification
  • Cleaning Validation
  • Enterprise Application Compliance Solutions
  • IT Infrastructure Qualification
  • Facility / Utility Commissioning and Qualification
  • Analytical Instrument/Equipment Validation
  • Strategy & Program Development
  • Assessments
  • Master Planning
  • Protocol Development & Execution
  • Software/21 CFR Part 11
  • Equipment
  • Program Outsourcing

Compliance & Quality Sys.

  • Consultation
  • Regulatory Gap Analysis
  • Program Development
  • GMP/QSR
  • FDA Readiness Audit
  • Planning, Implementation & Training

Clinical Study Compliance

  • GLP Assessments
  • GCP Compliance Assessments
  • Clinical Investigator
  • Sponsor
  • Monitor
  • Central Study File
  • Database and Data Mgmt
  • Institutional Review Board

Technical Service Provided

  • Validation Projects and/or Staffing
  • Clinical Systems Risk Assessment
  • Validation Planning
  • Vendor Auditing
  • Risk Assessment and Mitigation
  • User Requirements Gathering and Documentation
  • Validation Project Management
  • System Design Documentation (FRS, DS)
  • Qualification Protocol (IQ, OQ, PQ) Development and Execution
  • Validation Reporting
  • Traceability Matrices
  • SOP Development and Review
  • Validation Gap Analysis and Remediation
  • 21 CFR Part 11
  • Test Script Creation & Execution
  • Quality & System Audits
  • Training & Education Programs
  • HIPAA
  • HL7
  • Sarbanes-Oxley
About Us
Validation Associates is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives. Our goal is to achieve positive change for our clients through tools and methodologies that provide immediate impact, sustainable results, and knowledge transfer that continue to bear dividends over time. Our global network of pharmaceutical, biotech and medtech experts works with you to define and deliver effective solutions to the complex challenges affecting your business in all areas from innovation to regulation and patient engagement.
We Commit to
  • Quality and Excellence in everything that we do.
  • Strategic management and long-term relationships.
  • Fostering individual growth and team development.
  • Integrity and loyalty
  • Focus on delivering Value
  • Open and Honest Communication
Resources
White Paper

White Papers

Use Cases

Use Cases

Use Cases

Useful Links

Get in touch
  •    131 Elden Street, Ste.204
          Herndon, VA 20170
  •    703-291-0203
  •    703-935-1467
  •   [email protected]
          [email protected]
          [email protected]
  • Copyright Validation Associates.
  • Terms of Use
  • Handmade by IMENSO