Manufacturing Onshoring for Life Sciences

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Thought leadership

Three Supply Chain Strategies for Tariff-Impacted Medical Devices

Onshoring or reshoring highly regulated biotech and pharmaceutical operations means navigating a maze of risks: strict FDA and global standards, tight timelines, supply chain pressure, worker safety requirements, and compliance scrutiny at every step. Bringing complex operations online requires coordinating chemistry, electrical engineering, manufacturing, environmental controls, and safety systems.

Exponent provides clear guidance, trusted testing resources, and defensible documentation to support your onshoring or reshoring effort — from concept through operation — so you can bring facilities online faster, with greater confidence and control. Our multidisciplinary teams offer:

Engineering and construction consulting to help you evaluate building design, manage schedules and costs, and validate compliant facilities.
Product quality assurance testing so you can verify performance, safety, and reliability before issues reach regulators or patients.
Expert regulatory support and defensible documentation that helps you meet standards and respond to regulators.

CAPABILITIES

Exponent provides a one-stop shop for facility, process, and regulatory expertise, helping you achieve compliant, scalable manufacturing faster. Download our service brochure:

For Pharmaceutical Manufacturers
For Biotech Manufacturers

Our construction planning and consulting experts provide integrated project and program management, schedule and cost controls, and technical advisory services for biotech and pharmaceutical manufacturing facilities. We apply risk‑based project lifecycle management — including phased project scheduling, change control, process validation, and integration with commissioning and qualification — to support complex, highly regulated capital projects from early planning through facility turnover. Through rigorous preconstruction planning, proven governance frameworks, and early collaboration with project stakeholders, Exponent helps mitigate cost, schedule, quality, and regulatory risks to achieve on‑time and on‑budget project delivery.
Exponent provides complete support for manufacturers of highly regulated products, from premarket evaluations to technology transfer, process development, validation testing, modeling, gap assessments, and root‑cause analysis.
Our engineers and scientists work together across the full product lifecycle — from early development and testing through quality management, manufacturing support, inspections, compliance, and corrective action — giving you the confidence to bring trusted products to market.
- Product and Process Transfer Support
- Identification and Review of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)
- Review of Product Historical Deviations, Investigations, and CAPAs
- Analytical Method Transfer Support
- Process Gap Assessment and Risk Analysis
- Process Performance Qualification (PPQ) Planning and Execution Support
Biotech and pharmaceutical manufacturing facilities require far tighter control of indoor air conditions than typical manufacturing environments, making HVAC design critical. Precise control of particulates, temperature, humidity, and pressure differentials is essential to product quality and safety. Exponent's mechanical engineers bring decades of experience addressing these challenges across biomedical manufacturing and other critical environments — including hospitals, laboratories, cleanrooms, and wafer fabrication facilities — applying this expertise throughout facility design, construction, and commissioning.
- Validation Master Plan Execution
- Calibration
- Facility Inspection
- Chemistry, Manufacturing, and Controls (CMC) Assessment
- Root-Cause Analysis of Commissioning Issues and Equipment Performance
- HVAC Commissioning Assessment and Test, Adjust, and Balance (TAB) Reports vs. Design Requirements
- Complete Systems Evaluations
- ISO-Certified Audits, Including ISO 9001:2008 and ISO 33000 Standards
- PFMEA and General Risk Assessments
The biotech and pharmaceutical regulatory landscape is constantly evolving, creating new challenges for manufacturers. Our regulatory experts have decades of experience with agencies like FDA, EPA, U.S. Department of Agriculture, and we continually track the latest developments. We work closely with you to implement custom testing strategies and documentation that meets requirements — and we can interface with agencies to help expedite processes.
- Quality system assessment for new site(s)
- Type V DMF Review
- Current Good Manufacturing Practice (CGMP) compliance with facility and manufacturing operations
- FDA interactions associated with CGMP compliance
- FDA interactions associated with manufacturing validation
- Technical support for CMC responses to FDA
- Third-party review of submission documents

Capabilities

Our Capabilities Are Unparalleled

Exponent helps biotech and pharmaceutical manufacturers build compliant, safe, and productive facilities. Our multidisciplinary experts offer design evaluation, construction, manufacturing, and building systems support, as well as assistance with end-product quality assurance testing.

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Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.