Life Sciences Advisory

EXECUTION CERTAINTY.

Board-ready transformation advisory for high-stakes turnarounds, post-acquisition integrations, and commercial scale-up across regulated industries.

Embedded leadership model where execution risk is high, timelines are compressed, and enterprise value depends on right first-time outcomes.

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25+ Years Experience

Top Tier Pharma to Start-up Leadership

Enterprise Scale Transformation

Prioritize, Accelerate, and Reduce Risk

Core Capabilities

Multiple disciplines. One integrated practice.

From enterprise strategy to tactical execution, Landen translates strategic intent into operating models, investment priorities, and measurable value creation.

Business Strategy & Commercial Enablement

Operating model design, commercial and technical enablement, manufacturing strategy, and transformation leadership across regulated life sciences portfolios. Focused on growth, governance, and execution where regulatory complexity and capital exposure intersect.

Growth Strategy CMO Strategy Supply Chain Strategy Transformation

Quality Transformation & Remediation

Enterprise Quality System remediation, deployment, and modernization from crisis stabilization through inspection-readiness and sustained compliance across devices, combination products, diagnostics, and digital health assets.

FDA QMSR / EU MDR / EU IVDR / MDSAP CMO Oversight Late-Stage Clinical GMP Operations

External Manufacturing & Supply Chain

External manufacturing and supply chain strategy across CMOs and external partners, including due diligence, partner qualification, governance model design, and portfolio optimization. Hands-on leadership for outsourced manufacturing, clinical supply chain, and post-acquisition integration.

Due Diligence Supply Chain Governance Risk Management

Due Diligence & M&A Support

Support for private equity and venture capital investors, including technical and regulatory diligence, integration planning, and identification and planning for value creation opportunities. Post-close execution certainty, not just pre-deal assessment.

Due Diligence Integration Cost Improvement Investors

Who We Serve

Deep Focus Across Regulated Life Sciences Industries

Boards, executive teams, and investors across regulated life sciences — particularly in development-stage and growth-phase companies where hands-on leadership and execution experience matters most.

Medical Device & MedTech
Biotechnology
Pharmaceutical & Specialty Pharma
Combination Products
Diagnostics & Digital Health
Contract Manufacturing Organizations (CMOs)

Who Calls On Us

Service Providers

Mid-sized & large pharma service providers sharpening value propositions and growth models

Biotech

Early- and mid-stage biotech building partner strategies and scalable operations

Pharma / MedTech / Medical Device

Companies engaged in complex enterprise transformation, building sustainable compliance or integrating business units

Investors

Firms requiring operating partner diligence, integration planning, and execution governance

Track Record

Demonstrated Successes

Results across enterprise remediation, asset scale-up, post-acquisition integration, commercial launch, and cost / continuous improvement initiatives.

Initiatives are anchored in accountable leadership, budget discipline, and regulatory compliance.

Scale-Up

Led diagnostic asset integration across quality and operations. Secured $220M in funding; onboarded operations, quality, and external supply chain resources. GMP manufacturing and lab restart in 6 months to first lot to stock.

Revenue

Developed business development model generating ~$10M per year in large-scale manufacturing & lab equipment sales across Pharma and MedTech.

Leadership

Led 160-person organization with a $40M budget supporting ~300 external partners & ~300 assets.

Remediation

Led enterprise QMS remediation across 10 sites and 35 CMOs covering 60+ global processes for Top 5 Pharma.

Launch

Led asset under FDA EUA through manufacturing start-up; two ISO audits; enabled production of 1.5M units/quarter.

Growth

Built and scaled global quality/technical organizations (10x growth over 3 years); built device development and GMP testing labs.

How We Work

Embedded Leadership, Not Just Advice

Transformation Lead

Reset operating models and deliver outcomes on compressed timelines with C-Suite and Board level accountability.

Executive-Level Business Development

Corporate Strategic Planning for small to mid-size company growth planning and innovation for new products and services. In person strategy sessions available.

Embedded Advisor

An embedded partner with accountability to deliver.

Operating Partner to Investors

Diligence, integration, value creation plans, and execution governance for private equity and venture capital investors.

Engagement Model

Personal advisory practice providing senior, hands-on execution leadership.

Engagements include Board-level reporting cadence, direct accountability for outcomes, and the ability to assemble a focused senior execution team as required.

Not a large consultancy — a deliberately small, senior practice built for high-stakes situations.

"Execution risk is high. Timelines are compressed. When enterprise value depends on right first-time transformation."

About

Nick Mandala

A board-ready life sciences executive and transformation leader with 25+ years of experience leading high-risk transformations, post-acquisition integrations, and commercial scale-ups across regulated environments.

He has held executive accountability for regulatory outcomes, capital deployment, and execution across complex portfolios spanning medical devices, combination products, pharmaceuticals, diagnostics, and digital health.

Nick translates strategy into practical operating models, investment priorities, and measurable value creation — operating comfortably within complex matrixed organizations or within a start-up environment.

Life Sciences Biotech Pharma Services MedTech Combination Products Diagnostics Digital Health

What Sets Us Apart

Advice or Advice & Execution

We work alongside your teams to get things done right.

Cross-Functional Depth

Multiple Disciplines in a boutique practice to deliver strategy and execution.

Built for High Stakes

When execution risk is high and timelines are compressed, this is the practice built for that environment.

Get In Touch

Let's Talk

Whether you're navigating a transformation, planning an integration, or facing a quality challenge — start with a conversation.

Connect with Nick Mandala on LinkedIn