About Us
Our Mission:
FDA Compliance Specialists, Inc., headquartered in New York, NY, specializes in providing Global GxP, Medical Device, 21 CFR Part 11, and Supplier Quality Auditing, Computer System Validation, Inspection Readiness, and FDA Compliance and Quality Training Services to the Pharmaceutical, Medical Device, and Biotechnology regulated industries. The Quality of our services are best in class meaning we provide more benefits and value-added services for less money! Our cost-effective, highly credentialed FDA Compliance Specialists strengthen and improve the effectiveness of corporate internal and global supplier audit programs, computerized systems compliance, inspection readiness, and quality management system initiatives. We take pride in helping our clients ensure the quality, safety, and compliance of regulated products provided to consumers or patients.
Providing highly experienced, cost-effective Global QMS (Quality Management System) Auditing, Computer System Validation, Inspection Readiness, and FDA Compliance Training services by FDA Compliance Specialists globally, on demand is at the heart of everything we do!
Our Story:
We’ve always felt that the effectiveness of Global QMS Auditing, Computerized Systems Compliance, Inspection Readiness, and ongoing FDA Compliance and Quality Training are critically important to mitigate regulatory non-compliance risks and to help ensure the quality and safety of regulated products provided to consumers or patients. Supply chain globalization is a continuous challenge and many Pharmaceutical, Medical Device, Biotechnology, and Heatlhcare supplier companies must manage and execute an increasingly challenging and demanding internal and/or supplier audit program, inspection readiness, computerized systems compliance, and FDA Compliance Training without adequate resources.
Our highly credentialed FDA Compliance Specialists average over 15 years of hands-on regulated industry experience and we are focused on our core expertise. Our FDA Compliance Specialists have conducted hundreds of audits for some of the most highly recognizable and trusted organizations in the world to support their internal and supply chain auditing. Our industry experts provide Internal and Supply Chain Auditing services, Inspection Readiness services, Computer System Validation services, and FDA Compliance and Quality Training services integrated from our extensive experiences working with customers and integrating best industry standards and practices along the way.
Whether its dealing with an urgent audit request, or managing an entire supplier audit program; whether it’s providing Computer System Validation or Inspection Readiness services to help mitigate regulatory non-compliance risks, unnecessary / unwanted regulatory observations, and/or potential expensive delays in FDA approval; or it’s providing FDA Compliance and Quality Training to help highly regulated industries arm employees with the skills, tools, and knowledge needed to mitigate risks, improve corporate compliance, and improve their overall on-the-job effectiveness, our FDA Compliance Specialists have the knowledge, expertise, industry experience, and solutions to meet these needs.