Reshoring

Services

In an era of supply chain disruptions, geopolitical risk, and increased regulatory scrutiny, many life science companies are making the critical decision to reshore their manufacturing operations to the United States. EMMA International is the trusted partner for companies across pharmaceutical, biotech, medical device, and biopharma sectors that are seeking a strategic, cost-effective, and compliant path to bring operations back stateside.

Our reshoring services are end-to-end—from facility design and regulatory approvals to workforce support, quality systems implementation, and project execution. Whether you’re moving API production, sterile injectables, combination products, or medical device assemblies, we help you do it right and do it fast.

Why EMMA International for Reshoring?

FDA & Global Regulatory Expertise: Deep understanding of 21 CFR Parts 210/211, 820, 4, 600s, ISO 13485, ICH, and EU MDR.
Integrated Quality, Regulatory & Engineering Services: One-stop shop for compliant scale-up.
Contingent Labor & Professional Services at Scale: Cost-effective augmentation models for QA, RA, validation, and operations staff.
Proven Success Across Modalities: Experience in pharma, MedTech, sterile manufacturing, biologics, and diagnostics.

Reshoring Services We Offer

Bringing Life Science Manufacturing Back Home—Strategically, Efficiently, and Compliantly

Strategic Planning & Feasibility Assessment

Market assessment and cost modeling
Regulatory impact analysis (FDA, EU, and ROW)
Supply chain audit and vendor rationalization
Risk-based go/no-go decision support

Site Selection & Facility Readiness

GMP facility layout planning (ISO 7/8, Grade C/D, cleanrooms)
URS, FRS, and equipment qualification planning
Buildout oversight and CQV coordination
Tech transfer strategy and documentation

Regulatory Compliance & Quality Systems

Turnkey QMS design and implementation
Regulatory pathway analysis for NDA, ANDA, 510(k), PMA, De Novo, and BLA products
Documentation remediation and audit readiness
Supplier quality and raw material compliance

Engineering & Validation Support

Equipment validation (IQ/OQ/PQ)
Process validation (PPQ), cleaning validation
CSV and software QMS infrastructure
Facility, utility, and environmental monitoring validation

Workforce Scaling & Contingent Labor

Contract staffing of QA/QC, validation engineers, regulatory professionals, and project managers
Staff training on FDA requirements, aseptic techniques, and GDP
On-site and remote support models

Pharmaceutical API & Fill/Finish Reshoring – New Jersey

A global pharmaceutical firm engaged EMMA International to lead the relocation of API and sterile injectable fill/finish operations from India to New Jersey. EMMA provided:

Biotech Diagnostic Production Expansion – North Carolina

A molecular diagnostics firm expanded into U.S.-based production of PCR reagents and consumables. EMMA led:

Medical Device Assembly Relocation – Midwest U.S.

A Class II device manufacturer sought to relocate production of a blood glucose monitoring system from Mexico to Michigan. EMMA supported:

Regulatory change control submission strategy (NDA/ANDA)
Facility commissioning and IQ/OQ protocol execution
GMP-compliant workforce recruitment and training
QMS remediation and reinspection preparation
→ Outcome: FDA approval granted within 8 months; commercial launch achieved on schedule.

Facility design review and cleanroom compliance audits
Process validation and sterility assurance testing plans
QA staff onboarding and training
→ Outcome: Product released to U.S. market under EUA; full QMS aligned with ISO 13485 within 90 days.

Facility design review and cleanroom compliance audits
Process validation and sterility assurance testing plans
QA staff onboarding and training
→ Outcome: Product released to U.S. market under EUA; full QMS aligned with ISO 13485 within 90 days.