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We help leaders and organizations in FDA-regulated industries transform quality and compliance challenges into control, operational excellence, and long-term sustainability.
Facing Warning Letters, FDA 483s, or serious quality issues can be overwhelming. However, with our expert guidance, tailored recommendations, and your team’s commitment to implementing solutions, full compliance can be achieved in a fraction of the time.
This process restores trust, safeguards operations, and strengthens your company’s reputation.
The result? Safe, high-quality products, peace of mind, and significant long-term savings by avoiding reputational damage, product recalls, and costly operational disruptions.
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"Partnering with Life Sciences and Technology Consulting” was a game-changer for our organization. Faced with a critical FDA warning letter, we needed expert guidance to navigate complex regulatory challenges swiftly and effectively. Their team demonstrated unmatched expertise in pharmaceutical compliance, delivering strategic solutions that not only addressed the FDA's concerns but also strengthened our overall quality management systems. Thanks to their support, we developed robust corrective and preventive actions (CAPA), enhanced our laboratory practices, and implemented comprehensive training programs that significantly improved compliance. Their proactive approach and tailored solutions provided us with the confidence to meet regulatory standards and maintain the integrity of our products. I highly recommend Life Sciences and Technology Consulting to any pharmaceutical company seeking excellence in regulatory compliance, data integrity, and operational efficiency. Their insights and support were instrumental in helping us regain compliance, protect our market presence, and restore stakeholder trust.
Partnering with LSTC was a turning point for our organization. After receiving a multi-observation FDA 483 and facing significant data integrity and CGMP challenges, we were under immense pressure to respond quickly and effectively. LSTC stepped in with unparalleled expertise, bringing in ex-FDA investigators, global SMEs, and a structured, risk-based remediation approach that not only addressed each finding but also strengthened our entire quality system. What impressed us most was the team’s ability to integrate seamlessly with our operations—conducting onsite gap assessments, hosting mock inspections, overhauling our SOPs, and preparing us for reinspection in under six months. Their dedication, clarity, and command of FDA expectations gave our executive team and QA staff full confidence throughout the process. Thanks to LSTC’s support, we not only resolved the FDA concerns but emerged with a more resilient compliance framework and renewed access to the U.S. market. I highly recommend LSTC to any organization navigating complex regulatory issues or seeking long-term compliance excellence.”
Navigating FDA compliance as an OTC manufacturer is never easy especially when you're hit with multiple 483 observations. We engaged LSTC after a colleague recommended them, and I can confidently say it was the best decision we made. Their team brought unmatched regulatory expertise, including ex-FDA investigators who quickly assessed our gaps, overhauled our SOPs, and aligned our documentation with 21 CFR Part 211. They worked closely with our QA, production, and labeling teams to implement sustainable CGMP controls while keeping our operations running smoothly. LSTC didn’t just help us remediate they helped us transform. We are now inspection-ready, confident in our systems, and back on track with our U.S. distribution plans. I highly recommend LSTC to any OTC manufacturer looking for serious, experienced compliance partners.
As a growing biotech company advancing our first clinical candidates, we needed a regulatory partner who understood both the science and the compliance landscape. LSTC delivered on every front. From advising on aseptic manufacturing and sterility validation to preparing us for FDA interactions and CMC readiness, the team demonstrated deep experience in biologics, ATMPs, and risk-based quality frameworks. Their consultants didn't just check boxes they helped us build a quality system designed to scale with our pipeline. LSTC became a true extension of our team, providing strategic insight, hands-on support, and critical deliverables under tight timelines. I wouldn’t hesitate to work with them again or recommend them to other emerging biotechs looking to get it right from the start.
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