• FDA

Welcome To Validation Associates

Validation Associates LLC is a premier provider of business and technology solutions designed to enhance and maximize the operational performance of its customers through the adaptation and deployment of advanced information technology and engineering services Helping clients achieve their IT and business objectives in a professional, timely and cost-effective manner is Validation Associate's primary goal. Our clients consistently rate us #1 in technical expertise and client service. We are proud that more than 80% of our engagements come from repeat business and client referrals. We have the experience, expertise, and commitment to meet all of your validation and compliance staffing needs. We Welcome you to our website and invite you to discover our services.
Validation Associates was founded on the premise that biotechnology, medical devices and pharmaceuticals hold the promise of a better future for everyone – making good on that promise requires innovative approaches, world-class science, regulatory know-how and a team dedicated to bringing all of it together.

Our Services

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Why Choose Us

Validation Associates has successfully provided validation & staffing services to leading global corporations in regulated businesses such as Pharmaceuticals, Biotech and Medical Devices. Through collaboration, we exceed our clients’ needs by delivering innovative, flexible, multi-disciplinary solutions within engineering, CQV, CSV, project management, automation, and GMP compliance. We are a client-centric organization providing End-To-End solutions from inception and feasibility through to handover and technical support for commercial production.


Deviation and Document management

Gap/Risk assessment

Recalls, MDR's and complaint handling

Guidelines, procedures, and policies for Part 11

Vendors and IT compliance

Writing submissions, documentation

AER's, PMA's, IDEt

Remediation/resolution management

FDA GxP (GMP, GCP, GLP) Compliance

Validation Support Processes (VSP)

Validation protocols (IQ, OQ, PQ)

IT infrastructure, and 21 CFR Part 11

Why Validation Associates →


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


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,Cambridge, MA
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