Quality + Compliance Consulting
Quality Systems Consulting
Where quality operations may be a cost center for some, truly evolved life sciences organizations know that a proactive approach to quality yields far more than a passing grade – it propels your whole business forward.
Learn MoreLIMS Consulting
We bring industry-recognized excellence to LIMS and laboratory operations to help your organization evolve your strategy, processes, and systems to a place beyond compliance to real business value.
Learn MoreDigital Labs
New technologies and capabilities afford life sciences businesses the opportunity to digitize lab operations for countless benefits to cost, quality, efficiency, and performance. We help businesses identify, launch, manage, and optimize digital lab transformation initiatives large and small.
Learn MoreData Integrity
At some point, maintaining data integrity was as simple as ALCOA. But, as we continue to collect and store data at a nearly exponential rate, it’s not something that an acronym alone can solve anymore.
Learn MoreInspection Readiness
Preparing for inspection is a key to successful FDA approval of your clinical trial or product commercialization. It is necessary to identify the essential activities to become inspection ready.
Learn MoreGxP Compliance Strategy
GxP Compliance Strategy – it sounds fairly straightforward. What most organizations fail to realize is the untapped potential for strategic value that a pragmatic and scalable approach to compliance can deliver.
Learn MoreRemediation Services
Our approach to remediation quickly identifies the cause and subsequent solution to gaps in your compliance position. We are unwaveringly focused on enabling your business to do what it does best – delivering safe and effective treatments to your patients.
Learn MoreCSA and Validation Strategy and Services
The life sciences industry lives and breathes innovation – nearly every company is looking for the next big thing. But all the breakthrough drug discoveries and technological leaps forward mean little without a validation strategy that guarantees a replicable level of quality and efficacy.
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Contact Our Quality + Compliance Consulting Team
Click through to contact us online or give us a call or email anytime.
Phone: (919) 484-4400
Email: info@clarkstonconsulting.com