Broadsea

Manufacturing Technology Strategy for FDA-Regulated Industries

Pharmaceutical • Biotech • Medical Device • Contract Manufacturing

Fortune 500 expertise. Fractional pricing. Zero learning curve.

Services

Digital Manufacturing Readiness Assessment

30-day engagement

Strategic evaluation of your manufacturing technology capabilities, current IT footprint, and digital roadmap.

  • Technology landscape assessment & gap analysis
  • System validation readiness review
  • AI/automation opportunity assessment
  • 3-year technology roadmap

Manufacturing Technology Implementation Leadership

6-12 month engagement

Strategic project leadership for MES, LIMS, SAP, or automation system deployments in GMP environments.

  • Regulatory strategy & CSV oversight
  • Vendor accountability & management
  • Risk management & data integrity
  • Zero-downtime go-live planning

Fractional Director of Manufacturing IT

6-12 month engagement

Strategic technology leadership for FDA-regulated operations without the full-time commitment.

  • Manufacturing IT system oversight
  • FDA inspection readiness preparation
  • Cross-functional coordination
  • Technology investment strategy

AI & Automation Strategy

6-week engagement

Identify high-ROI AI and automation opportunities within regulatory constraints.

  • Regulatory-compliant use case development
  • ROI analysis with payback periods
  • Technology vendor evaluation
  • Proof-of-concept roadmap

Why Broadsea

Fortune 500 Pharma Pedigree

10+ years leading manufacturing technology at one of the world's largest pharmaceutical companies.

Proven Implementation Leadership

Multiple enterprise-wide and site-specific system deployments including SAP S/4HANA, EWM, and manufacturing execution platforms.

Regulatory Expertise Built-In

Deep understanding of 21 CFR Part 11, data integrity guidance, and CSV requirements. Compliance is never an afterthought.

Immediate Availability

Start within 1-2 weeks. No 6-month search process, no 90-day ramp-up. You get productive expertise from day one.

The Broadsea Advantage

Speed

Start in 1-2 weeks, not 6 months

Cost-Effectiveness

30-50% less than full-time Director

Risk Mitigation

Proven methodology prevents costly mistakes

Credibility

Fortune 500 expertise opens doors

Objectivity

No vendor allegiances or technology biases

Schedule a Consultation

Complimentary 30-minute consultation to discuss your manufacturing technology needs.

Book a Consultation