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About Us

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.

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.

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.

Services Offered
  • LSTC provides a full range of services to help organizations in FDA-regulated industries
    achieve compliance and operational excellence. These include:
  • Compliance and Regulatory Consulting: LSTC provides tailored support to resolve compliance gaps, restore quality systems, and ensure inspection readiness. Services include quality systems evaluation, risk mitigation, regulatory submission guidance, and effective responses to FDA 483s or Warning Letters with corrective and preventive actions.
  • On-Demand Expertise: Providing skilled professionals for QA/QC, validation, training, manufacturing, and other critical functions, while sourcing top-tier regulatory and technical talent to enhance client teams and ensure compliance success.
  • Data Integrity & Validation: Addressing data reliability challenges and providing expertise in validation, qualification, and training.
  • Audit & Inspection Readiness: Conducting Performing due diligence audits, pre-approval inspections, follow-up inspections, mock inspections, and operational assessments to guarantee compliance and readiness.
  • Facility Design & Qualification: Supporting compliant facility design, planning, and qualification.
  • Remote Teleconsulting: Delivering expert guidance virtually for flexible and efficient support. Key Focus Areas:
  • Quality Assurance (QA) & Quality Control (QC)
  • Regulatory Affairs
  • Compliance Remediation
  • Inspection Readiness
  • Manufacturing

  • Who Do We Serve? LSTC partners with a diverse range of FDA-regulated entities, including:
  • Pharmaceutical
  • Biotechnology
  • Medical device and combination product manufacturers
  • Contract Research Organizations (CROs)
  • Analytical testing laboratories
  • Contract Development and Manufacturing Organizations (CDMOs)
  • Case Study Examples:
    • FDA 483 Remediation: LSTC resolved FDA 483 findings for a pharmaceutical company by implementing corrective actions, enhancing their quality management system, and restoring full compliance within 6 months, successfully avoiding a Warning Letter and ensuring sustained compliance.
      Inspection Readiness: LSTC ensured a midsize pharmaceutical company was fully staffed and inspection-ready within 6 weeks, resulting in zero major findings and safeguarding compliance.
      Compliance Timeline Reduction: By reducing compliance timelines by 50%, LSTC saved a biotechnology firm $11 million through lower costs and recovered revenue, enabling faster product approvals.

    LSTC’s expertise and proven strategies ensure that clients achieve compliance, protect their operations, and position themselves for long-term success in FDA-regulated industries.

    Attention to Detail

    At the heart of our existence lies attention to detail.

    Patient Safety

    We put strict emphasis on patient safety concerns.

    Our Services

    CONSULTING SERVICE

    Life sciences industry dynamics are constantly changing and shaping up in a global context, challenging businesses to constantly innovate and address any complexities that may arise in the process. Life Sciences and Technology Consulting strives hard to fully grasp and understand the challenges experienced in the evolutionary journey of its valued clients. Our expert team of skilled and experienced professionals constantly strive to deliver solution-oriented success driven results.

    Industries

    Pharmaceutical
    Pharmaceutical industry is highly dominated and challenged by its constant evolutionary environment and latest breakthroughs in drug related technologies...
    Biopharmaceutical
    The bio pharmaceutical industry is a maturing industry with immense potential of becoming the core of the pharmaceutical industry. However, for that, it is important to drive significant transformation...
    Over the Counter
    Every year there is a huge number of over the counter drugs being marketed in the United States. Therefore, FDA imposes strict regulation criteria on those conducting OTC drug businesses.
    Medical Devices
    Life sciences companies selling medical devices are heavily regulated and must adhere to certain practices and follow a strict code of conduct to avoid permanent damages.

    Our blogs

    Card image cap
    Addressing Lack of Diversity and Inclusivity in Response to COVID-19

    Author: Sarah Anderson

    Date: June 06, 2020

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    How an Intelligent Enterprise Must Navigate the Economic Impact of Covid-19

    Author: Sarah Anderson

    Date: June 06, 2020

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    The Impact of COVID-19 on US Hospitals - Is it Worse Than Predicted?

    Author: Sarah Anderson

    Date: June 06, 2020

    Our Clients