ALKU Quality works in the areas of quality and compliance within the medical device, pharmaceutical, biotechnology and related industries. ALKU Quality delivers methodology and resources to ensure compliant, effective and efficient execution of quality system requirements. Keeping up-to-date with applicable regulations and emerging industry trends, our team is dedicated to ensuring that every client meets FDA rules and regulations.
At ALKU Quality we utilize a team of highly specialized experts to fulfill remediation, maintenance, and environmental needs, as well as many other quality initiatives nationwide. These individuals are veterans in their fields with specialized experience in various backgrounds. Our consulting experts are well versed in categories ranging from quality, compliance, regulatory, and manufacturing, to auditing professionals from the life sciences industry. These professionals include ex-FDA investigators and Lean-Six Sigma black belts, hand-selected to best suite our client's needs. ALKU Quality maintains a high level of involvement with our clients as new skills, systems, and processes are internalized and put into practice.