Specialist pharma consulting. Make it. Prove it. Own it.

Brendan Walsh  ·  Principal

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What We Do

Make It

Formulation science, process engineering, scale-up, and tech transfer. We bring three decades of hands-on pharma expertise to the product and process challenges that determine whether a drug gets made, and made reliably. Oral solid dose, nasal sprays, topicals, liquids, semi-solids. OTC, Rx, dietary supplements, medical devices.

Prove It

Validation, GxP, QbD, and regulatory readiness. Getting the product to work is only half the job. We make sure the process holds up under scrutiny. FDA Pre-Approval Inspections, process validation strategy, technical risk assessment, and CMC support.

Own It

Quality systems, data architecture, and regulatory documentation. We help organisations build the infrastructure that makes compliance sustainable, not a one-time effort but an embedded capability. Enterprise quality systems, laboratory informatics, PLM and specification data management, technical standards and SOPs.

— The Ballymote Group —

Who We Work With

Specialist depth
for the clients who need it most.

We work with a select group of clients where the technical stakes are high and generalist hours aren't enough.

Smaller Pharma & CDMOs

You have the science. We bring the institutional knowledge that comes from decades of doing this at scale. The scale-up experience, the process robustness, the regulatory judgment that only comes from having been there before.

Private Equity & M&A Advisory

Technical due diligence on pharma manufacturing assets and product portfolios. We answer the question that financial diligence can't: is this asset what it claims to be? Technical Due Diligence is available as a standalone engagement.

Project Management Consultancies

Pharma technical SME support for GMP facility builds. CQV strategy, IQ/OQ/PQ programme leadership, process validation, schedule integration, and regulatory milestone definition for GxP facilities.

Boutique Pharma Consultancies

Peer-level collaboration for engagements that need specialist bench depth. Formulation, process, validation, brought in where the expertise is needed most.

Market Intelligence

Consumer health intelligence. Three verticals. Updated monthly.

An ongoing intelligence platform tracking ingredient trends, evidence quality, regulatory signals, and competitive moves across three consumer health verticals. Each vertical delivers a trend radar, monthly pulse, white space analysis, and regulatory alerts.

Dietary Supplements

Vitamins & minerals, gut health, nootropics, beauty & longevity, and women's health. 31 ingredients tracked across five segments.

OTC & Consumer Health

Claim landscape, reformulation signals, Rx-to-OTC pipeline, and competitive brand moves across four therapeutic segments.

Oral Health

Ingredient innovation, clinical evidence, and regulatory positioning across five oral health segments. Fluoride, hydroxyapatite, and the microbiome.

What Each Vertical Delivers

Trend radar · Monthly pulse · White space analysis · Regulatory alerts. Access requires a brief registration.

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Brendan Walsh

About

Brendan Walsh

The Ballymote Group is built on three decades of pharmaceutical and consumer healthcare experience, from SmithKline Beecham through GSK to Haleon. Past engagements include leading multiple Rx-to-OTC switch projects, delivering a first-in-kind QbD NDA submission, and earning a President's Award for supply chain crisis mitigation.

Additional experience includes successfully defending novel regulatory methodology to FDA auditors during Pre-Approval Inspections, and resolving post-launch product issues before they became compliance events.

The name comes from Ballymote, the Walsh family's ancestral town in County Sligo, Ireland. It's also the name of our house. The home base, literal and figurative, of the practice.

We help smaller pharma companies and investors avoid the product and process mistakes that derail drugs and deals. If you've been pointed this way by someone you trust, we'd be glad to talk.

Brendan Walsh

Contact

Schedule a Conversation.

If you've been pointed this way by someone you trust,
we'd be glad to hear from you.

Brendan.Walsh@theballymotegroup.com +1 (908) 777-1165 LinkedIn

The Ballymote Group LLC
Blairstown, New Jersey