Industry Specialization Services

Contract Development & Manufacturing Organizations (CDMO)

Specializations:

• Drug-filled autoinjector manufacturing and scaling

• Combination product development and production

• Cleanroom device manufacturing

• FDA compliance and regulatory excellence

• International partnership development

Typical Engagements:

• Operations scaling ($40M→$130M proven methodology)

• NPI program development ($10M+ revenue per program)

• Cross-border manufacturing partnerships

• Post-acquisition integration and optimization

Medical Technology (MedTech) Devices

Specializations:

• Class 2/3 medical device manufacturing

• ISO 13485 certified operations optimization

• Interconnect assembly and high-complexity devices

• Manufacturing network integration

• International production transfers

Typical Engagements:

• Facility transformation and integration

• Manufacturing efficiency optimization (15%+ improvements)

• Supply chain and workflow optimization

• Cultural integration during M&A

Pharmaceutical Drug Delivery Systems

Specializations:

• Autoinjector manufacturing and assembly

• Cleanroom manufacturing environments (Class 6/7 cleanrooms)

• 21 CFR Part 820 compliance leadership

• Combination product regulatory compliance

Typical Engagements:

• Cleanroom operations optimization

• Manufacturing cost reduction initiatives

• Quality system implementation

Advanced Manufacturing & Interconnect Systems

Specializations:

• High-precision interconnect assemblies

• Complex electronic-mechanical integration

• International manufacturing partnerships

• Large-scale workforce management (500+ employees)

• Cross-functional team leadership

Typical Engagements:

• Manufacturing network optimization

• International expansion frameworks

• Organizational design and cultural transformation

• Lean manufacturing and continuous improvement

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