Services

Here to assist with your product and process development needs

Structured support across the full lifecycle — from early design through validated, high-throughput operations.

1 Product & Process Development

Designing and leading structured, step-by-step plans ("if this, then that") that move products and processes from concept through development and toward approval.

  • Research and diagnostic labs
  • Technology transfer — Validations and Verifications
  • Molecular biology techniques
  • Next-generation sequencing (NGS)
  • Assay development
  • Medical devices

2 Quality & Regulatory Pathways

Creating and improving quality management systems and operational processes — meeting your organization's needs.

  • Quality management system development & improvement
  • Design and development under Design Controls
  • CAP/CLIA/FDA regulations
  • Materials and equipment Qualifications

3 Automation & Digital Transformation

Leading or heavily influencing automation initiatives — moving teams from manual, paper-heavy processes to efficient, digital, high-throughput systems.

  • Process scale-up and increased robustness
  • LIS/LIMS development and implementation
  • End-to-end automation and systems integration
  • Digital transformation of lab operations — "Lab of the Future"
  • Liquid handling robotics

4 Program & Project Leadership

Serving as the person who asks smart, persistent questions and helps teams refocus on what truly matters: needs vs. wants, sequence of work, and pivoting when needed.

  • Technical program / project direction
  • Technical writing
  • Cross-disciplinary team facilitation
  • Project management

Not sure where your project stands?

Send a quick note about your needs — we'll figure out the gaps together to get you moving forward.

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