ABOUT US
Through extensive industry experience, Bitsy Romo-Sicairos (Q Cubed Consulting's founder) recognized a common challenge with other consulting firms. Many relied on cookie-cutter solutions that were compliant but failed to meet the unique needs of the organizations they served. To address this, Bitsy founded Q Cubed Consulting to provide quality consulting with an emphasis on building knowledge and offering solutions that are not only compliant on paper, but practical and sustainable. At Q Cubed Consulting, we specialize in delivering tailored Quality Compliance solutions for Pharmaceutical, Medical Device, Over-the-Counter (OTC), Cosmetic, and Personal Care companies.
We accomplish this by first getting to know your unique needs through a free consultation. From there, we maintain strong communication, ensure transparent billing, and weave the voice of your company into the fabric of your solutions plan. Schedule a free consultation now, to discover how Q Cubed Consulting can help your company reach its compliance goals.
Built on Experience Driven by Results
Quality Systems
With a wealth of experience in Quality Systems, Q Cubed Consulting has successfully implemented Quality Systems that have withstood the test of Compliance Audits. We also have experience in overhauling Quality Systems for mature companies struggling to manage processes that have become cumbersome over time and no longer work for an expanding company. Additionally, we have helped companies integrate electronic Quality Management Systems (eQMS) into their Quality structure.
Compliance Audits
From FDA to ISO, Q Cubed Consulting specializes in navigating the complexities of external audits. Our extensive experience includes hosting audits and managing backrooms. We support companies by preparing Subject Matter Experts, coaching Hosts, and conducting inspections to identify compliance issues so they maybe resolved prior to compliance audits. We also have experience with writing audit responses and assisting with 483 and Warning Letter management.
Integration
Q Cubed Consulting has assisted with integration following acquisitions. Our background in Project Management plays a vital role in our ability to assist with various integration activities ensuring a strategic focus on compliance and culture.
Training
From large off-site seminar style training to virtual and on-site team training, Q Cubed Consulting is experienced in all facets of quality training. We specialize in Quality System, Root Cause Analysis, and Micro Awareness training and can also provide tailored training based on your needs.
Biofilm Remediation
Q Cubed Consulting possesses significant experience in successful biofilm remediation for Purified Water Systems and Equipment Trains. This experience includes remediation of Burkholderia cepacia Complex and Ralstonia pickettii.
Root Cause Analysis and Corrective Action
From microbial contamination of product, to trending nonconformances leading to high scrap costs, and issues found during Post Market Surveillance, Q Cubed Consulting has helped companies find true root cause and mitigate risk of reoccurrences.
Contract Manufacturing
Contract manufacturers face unique challenges, including managing customer specifications and expectations, as well as navigating complex changeovers. Q Cubed Consulting's strong background working with Contract Manufactures allows us to effectively tackle these hurdles, providing tailored solutions that enhance operational efficiency and foster strong customer relationships between our Clients and their Customers while improving Quality Compliance.
Supplier Management
In addition to Contract Manufacturing, Q Cubed Consulting has experience working with Brands that largely rely on outsourcing formulation and/or manufacturing activities. This experiences paired with our background in Contract Manufacturing makes Q Cubed Consulting uniquely prepared to assist companies with their Supplier Quality needs.