Reach out to us. We’re here to assist you and answer your questions.
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Location
3430 S 3570 E,
Salt Lake City, UT, 84109
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Working Hours
Mon – Sat: 09.00am – 07.00pm
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Phone
801-573-9366
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contact@Koholaconsulting.com
Frequently Asked Questions
Answers to common questions about our services and how we can assist you.
Kohola Consulting primarily specializes in providing expert quality and regulatory guidance to companies within the medical device, pharmaceutical, and dietary supplement industries. Our extensive experience spans both large enterprises and agile start-ups within these highly regulated sectors.
We offer a comprehensive suite of consulting services designed to build and optimize your quality infrastructure. Our core areas include Quality Management System (QMS) development and implementation (FDA QSR, ISO 13485, MDSAP, EU-MDR), Design Controls, Corrective and Preventive Action (CAPA) systems, regulatory compliance and strategy, auditing services (internal and supplier), supplier qualification and management, risk management, and process/product/software validation programs.
Our approach is rooted in over 25 years of hands-on experience in tightly regulated environments. Led by Robert Malone, an ASQ Certified Quality Manager and Auditor, we possess deep expertise in FDA QSR (21 CFR Parts 803, 806, & 820), and have a proven track record of guiding successful FDA applications (e.g., IDE submissions) and managing FDA audits with minimal observations. We meticulously develop and implement QMS strategies that are not only compliant but also efficient and robust, ensuring your products meet global regulatory standards.
Our key differentiator is our results-driven, hands-on approach combined with extensive, real-world experience. We don’t just provide advice; we partner with you to implement practical, innovative solutions. Our track record includes significant achievements like streamlining document control by 70%, reducing adverse event misidentification by 97%, and successfully navigating complex regulatory challenges. We bring the expertise of an ASQ Certified Quality Manager and Auditor directly to your specific needs, translating deep knowledge into tangible improvements for your quality system and regulatory standing.