Make it. Prove it. Own it.

Specialist pharma consulting.

Three decades taking pharmaceutical and consumer-health products from formulation through validation, regulatory approval, and the quality systems that keep them on the market.

Brendan Walsh · Principal

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What I Do

Make It. Prove It. Own It.

Three disciplines. One practice. The full product-to-market journey: from first formulation to FDA filing to the quality systems that hold it all together.

01
Make It

Formulation science, process engineering, scale-up, and tech transfer. Three decades of hands-on pharma expertise applied 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 · Supplements
02
Prove It

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

Process validation FDA PAI readiness QbD CMC Technical risk
03
Own It

Quality systems, data architecture, and regulatory documentation. I help organisations build the infrastructure that makes compliance sustainable: enterprise quality systems, laboratory informatics, specification data management, and the structured-data foundations that underpin AI and predictive modelling in modern pharma operations.

Enterprise QMS Lab informatics PLM Data architecture AI readiness

Three decades behind names you'd recognise.

Flonase Sensodyne Tums Aquafresh Nicorette Centrum alli Panadol Abreva Polident Breathe Right Theraflu

I've taken products like these from idea to launch: formulation, scale-up, regulatory approval, and the process robustness that keeps them performing once they reach the shelf. Across dozens of successful launches, I've navigated the challenges your products will face, and that's the experience I bring to yours.

Who I Work With

Specialist depth
for the clients who need it most.

I help pharmaceutical and consumer health companies, and the investors behind them, avoid the product and process mistakes that derail drugs and deals.

I 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. I bring the institutional knowledge that comes from doing this at scale: the scale-up experience, the process robustness, and the regulatory judgment that only comes from having been there before.

Large Pharma & Consumer Health

Senior bench experience, on demand. Interim and surge SME support for the programs that strain internal bandwidth: quality-system transformation, FDA Pre-Approval Inspections, post-merger integration, and product-development data initiatives. The depth of a three-decade operator, without adding permanent headcount.

Private Equity & M&A Advisory

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

Technology Vendors

I know your buyers, because I've been one. Domain expertise for LIMS, ELN, PLM, and data-platform vendors selling into pharma R&D and quality: product and positioning input, voice-of-the-customer validation, and the credibility to turn technical capability into language buyers trust.

Brendan Walsh
SmithKline Beecham GSK Haleon

About

Brendan Walsh

I started at the bench, in formulation and process engineering, delivering the full technical package that takes a consumer insight through development, scale-up, tech transfer, and launch. Over three decades at SmithKline Beecham, GSK, and Haleon, I moved from the lab into Product Development leadership, then into the executive work: governing technical standards, integrating R&D organisations through mergers, and building the data foundations a modern pharma operation runs on. Bench to boardroom, on the products people reach for every day.

I built The Ballymote Group to put that range to work for others. The technical judgment that keeps a product on the shelf and through inspection is hard to hire and harder to keep on staff. That is what I bring, whether to a company that needs senior depth it can't justify full-time, or to an investor who needs to know what an asset is really worth.

The name works on three levels. Ballymote is the Walsh family's ancestral town in County Sligo, Ireland. It's also the name of my home, the literal and figurative base of the practice. And the initials of The Ballymote Group, BG, are what my mother called me growing up, short for Brendan Gregory.

Brendan Walsh

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.

01
Dietary Supplements

Vitamins & minerals, gut health, nootropics, beauty & longevity, and women's health. 32 ingredients tracked across five segments.

02
OTC & Consumer Health

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

03
Oral Health

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

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

Access the Intelligence Platform →

Contact

Schedule a Conversation.

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

Email

Brendan.Walsh@
theballymotegroup.com

Phone

+1 (908) 777-1165

LinkedIn

Connect on LinkedIn

The Ballymote Group LLC  ·  Blairstown, New Jersey