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About Our Company

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Life Sciences and Technology Consulting (LSTC) helps organizations in FDA-regulated industries turn quality and compliance challenges into operational strengths through tailored solutions. By specializing inn addressing critical issues resulting from FDA 483s and Warning Letters, we help clients rebuild trust, ensure operational continuity, and mitigate reputational and financial risks. With a focus on efficiency, measurable outcomes, and comprehensive support, we deliver end-to-end solutions that resolve immediate concerns while fostering long-term success.

Our deep regulatory expertise, customized strategies, proven compliance track record, cross-functional teams, and commitment to continuous improvement transform compliance challenges into opportunities for sustainable growth and operational excellence.

Heeda Jafarishahvarlu 

CEO & President

Meet Our Partners

Our Mission

LSTC is dedicated to helping FDA-regulated organizations deliver safe,high-quality products, achieve compliance, and build long-term operational success through expert guidance and tailored solutions.

Our Expertise

The LSTC team is composed of former FDA officials and seasoned industry professionals with decades of experience in regulatory, quality, and manufacturing roles.

Their deep industry knowledge and strategic approach ensure effective, customized
solutions for every client.

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Our Team

Meet Professional Team Members

Stephen Larry

Product Manager

Landak Nuver

Manager

Anne Mary

Analysict

Stephen Larry

Product Manager

Kelin Beets

Marketer

Anne Mary

Analysict

Built for Results: Strategic Consulting that Transforms Ideas into Growth

Senior Vice President of Quality and Regulatory

"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.

VP of Quality

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.”

QA Director

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.

VP of Quality and Regulatory

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.

Popular Questions

Guiding Life Sciences Toward Smarter, Safer, and Stronger Futures

“At LST Consulting USA, we don’t just provide advice—we build lasting solutions that empower organizations to innovate with confidence and integrity.”

We support clients across pharmaceuticals, biotechnology, contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), analytical testing laboratories, animal health, consumer health, and AI-driven life sciences solutions.
Our consultants bring deep expertise in FDA, EMA, ICH, USDA, and ISO standards. We provide strategic guidance, audit readiness, and quality system improvements to help organizations meet regulatory requirements while enhancing operational performance.

We believe every client is unique. While we apply proven frameworks and best practices, we always tailor our approach to fit the size, maturity, and goals of each organization.

Yes. We assist with specific, short-term projects such as remediation, process validation, or regulatory submissions, and we also build long-term collaborations focused on growth, transformation, and sustainable success.
We combine scientific expertise, regulatory insight, and operational know-how with a hands-on, collaborative approach. Our consultants work closely with your teams to deliver practical solutions that drive lasting impact.
It begins with a conversation. We’ll assess your needs, identify opportunities, and outline a tailored approach that addresses your most pressing challenges. Contact us today to take the first step toward building stronger systems, reducing risk, and unlocking new growth opportunities.