LIFE SCIENCES AND TECHNOLOGY CONSULTING

Life Sciences and Technology Consulting offers one stop solutions to all your life sciences consultancy needs and regulatory compliance requirements. Being the leader in innovation, patient health and clinical research consulting services, we offer viable solutions for your business to help you keep up with the ever so changing world of biotechnology.

LIFE SCIENCES AND TECHNOLOGY CONSULTING

Life Sciences and Technology Consulting offers one stop solution to all your life sciences consultancy needs and regulatory compliance requirements. Being the leader in innovation, patient health and clinical research consulting services, we offer viable solutions for your business to help you keep up with the ever so changing world of biotechnology.

LIFE SCIENCES AND TECHNOLOGY CONSULTING

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.