The Ballymote Group: Product Development, Digital Innovation, Quality & Compliance

Bridging AI Ambitions and Operational Reality

Strategic consulting for pharmaceutical and consumer healthcare companies navigating digital transformation. Over three decades of R&D leadership experience.

The pharmaceutical industry stands at an inflection point.

Companies are investing heavily in AI, digital labs, and data platforms. Yet many struggle to translate these investments into operational value.

The gap between technology promise and manufacturing reality isn't a technology problem. It's a knowledge integration problem.

Success requires someone who speaks both languages: the technical depth of formulation science and process engineering, and the strategic clarity of executive decision-making.

How I Help

From strategic roadmaps to hands-on implementation guidance, I help organizations unlock the value of their digital investments.

Digital Transformation Strategy

  • AI readiness assessments
  • Data maturity roadmaps
  • PLM/MDM strategy and implementation
  • Structured data architecture for ML

Formulation & Process Excellence

  • Quality by Design (QbD) implementation
  • Process development and tech transfer
  • FDA Pre-Approval Inspection prep
  • Analytical method development

Organizational Enablement

  • LIMS/ELN consolidation strategy
  • Cross-functional team alignment
  • Change management for digital initiatives
  • Training and capability building

Due Diligence & Assessment

  • Technical due diligence for PE/VC
  • Manufacturing capability assessments
  • Quality system gap analysis
  • Digital maturity benchmarking

Why Work With Me

1

Bench to Boardroom

Over three decades spanning laboratory bench work to executive leadership. I translate technical complexity into strategic clarity, and business objectives into actionable technical requirements.

2

Implementation Focus

Having led enterprise-scale initiatives across global organizations, I focus on what actually works in regulated environments. Not theoretical frameworks.

3

Bridge Building

The most valuable work happens at intersections: between IT and R&D, between legacy systems and AI aspirations, between regulatory requirements and operational efficiency.

Who I Work With

CDMOs

Modernizing operations while maintaining compliance

Mid-Size Pharma

Building digital capabilities without enterprise resources

Private Equity

Technical due diligence on healthcare investments

Technology Vendors

Life sciences market strategy and product-market fit

Ready to Connect?

Every engagement starts with a conversation. I'm interested in understanding your challenges and exploring whether my experience can help you move forward.

Send a Message

I typically respond within one business day.