Why Choose Validation Consultants?
We're dedicated to your regulatory compliance
Validation Consultants LLC is dedicated to helping FDA-regulated companies address regulatory and compliance requirements for computer systems software, processes and equipment. Working as a partner with a range of clients from global corporations to start-ups in scale-up mode, we assess compliance, validate systems, processes & equipment, enable quality assurance and develop policies and procedures for electronic data control.
We guide you through the process
We understand GMP, GCP and GLP and regulatory CSV compliance requirements and can guide you through any step in the process - from creating new processes for QA, validation and testing and writing SDLC documents to assessing compliance status, validating & testing software, equipment & process, managing FDA audits and implementing corrective actions.
We apply our deep expertise
From years of experience working with pharmaceutical and medical device manufacturers as well as consumer products companies regulated by the FDA, we apply best practices and deep domain experience to establish compliant and durable processes for electronic data control.
We work with you as a partner
Your success is our success. We work as your partner to expedite compliance programs and implement processes. We will work within an agreed scope of work and timeline, but can pivot to address your real-time needs. Available on-site or virtually according to your requirements, we work closely with your technical and scientific experts to achieve project goals on time and within budget.
We get results
We deliver the processes, documentation and best practices to streamline processes, ensure data security and verify regulatory compliance of electronic data so that our clients are ready for compliance audits.