Big-Four Expertise · Lean Execution
Life Sciences Advisory:
Strategy & Compliance
For Regulated Enterprises.
We help pharma, biotech, medtech, and regulated organizations turn investment theses into executable regulatory, digital, and AI roadmaps — delivered by senior practitioners, not associate teams.
$63B
M&A Merger Support
17k+
UDI Records Managed
3k+
Global Users Deployed
60+
AI Document Types
Core Practice
GxP & Regulatory Compliance
Part 11, HIPAA, QMS remediation, audit readiness
Growth Practice
Digital & AI Transformation
Cloud architecture, responsible AI, data analytics
Market Access
Federal & Commercial GTM
Procurement strategy, supplier diversity, RFP execution
Operations
Managed PMO & Vendor Governance
Outsourced operations, staff augmentation, quality cadence
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Strategy ConsultingRegulatory ComplianceGxP RemediationDigital TransformationM&A IntegrationLife Sciences AdvisoryAI RoadmapsFederal GTMManaged PMOVendor GovernanceStrategy ConsultingRegulatory ComplianceGxP RemediationDigital TransformationM&A IntegrationLife Sciences AdvisoryAI RoadmapsFederal GTMManaged PMOVendor Governance
Why American Dev Partners
The execution rigor of the Big Four — without the overhead.
Our principals have led transformation programs at the world's largest pharma, medtech, and government organizations. We bring that caliber of thinking to engagements of all sizes — deploying senior practitioners who understand both the regulatory landscape and the operational reality your teams face.
From strategy artifacts to audit-ready documentation, we don't just advise — we execute alongside you.
$63B
Merger consolidation support — Top-5 Pharma
17k+
UDI records · 3,500+ MDR submissions — Top-10 MedTech
60+
Clinical document types mapped for AI pilots — Global Biopharma
3k+
Global users deployed on Veeva Vault RIM — Fortune-20 Pharma
What We Do
Strategic capabilities built for regulated complexity.
01 / Strategy
Strategy & Transformation
We build the artifacts that drive organizational alignment — from pilot-to-enterprise scaling roadmaps to M&A integration playbooks and risk heatmaps.
02 / Compliance
Regulatory & GxP Compliance
End-to-end remediation across GxP, 21 CFR Part 11, HIPAA, and Quality Management Systems. We make you audit-ready, not just audit-prepared.
03 / Market Access
Market Access & Procurement
Navigating complex buying environments — from federal and state GTM to pharma vendor strategy, supplier diversity programs, and commercial launch modeling.
04 / Digital & AI
Digital & AI Transformation
Cloud architecture, data analytics pipelines, and responsible AI implementation designed for regulated environments where auditability is non-negotiable.
05 / Operations
Managed Operations & PMO
Outsourced program management, vendor governance frameworks, and specialized staff augmentation to fill critical operational gaps without permanent overhead.
06 / PE / VC
Private Equity & Venture Support
Stop integration friction before it kills EBITDA. From due diligence to portfolio company transformation and growth scaling for early-stage ventures.
Sectors We Serve
Deep sector expertise across the regulated enterprise.
Life Sciences
Pharma · Biotech · MedTech
Healthcare
Payers · Providers · Health IT
Private Equity
Sponsors & Portfolio Companies
Venture Capital
Growth & Early Stage
Government
Public Health & Civic Tech
Technology
SaaS & Regulated Platforms
Enterprise
Fortune 500 & Global Operations
Start-Ups
Founder-Led Growth Companies
Representative Outcomes
Measurable impact at the world's leading organizations.
Top-5 Pharma · M&A
Consolidated 100+ clinical systems and led reporting readiness for a landmark biopharma merger.
M&A Integration
$63B
Merger transaction value
Top-10 MedTech · UDI
Managed global UDI compliance program across thousands of product records and MDR submissions.
Regulatory Compliance
17,000+
UDI records managed
Global Biopharma · AI
Designed clinical document ontology to automate AI drafting pilots across the organization.
Digital & AI
60+
Document types mapped
Fortune-20 Pharma · RIM
Led OCM and global rollout of Veeva Vault RIM platform for enterprise regulatory operations.
Managed PMO
3,000+
Global users deployed
State Government · COVID-19
Operationalized mass vaccination clinic networks and public health logistics infrastructure.
Government
Statewide
Operations scaled
Resource Library
Capability sheets, briefs & guides for leaders.
Executive Brief
Navigating GxP & AI Adoption in Regulated Life Sciences
Strategic guidance for regulated organizations navigating AI implementation alongside GxP obligations.
Download Brief →Capability Sheet
Private Equity & Portfolio Company Advisory
How we help PE sponsors stop integration friction before it kills EBITDA in regulated holdings.
View Sheet →Capability Sheet
Government & Public Sector Capabilities
Federal and state procurement strategy, public health operations, and civic technology advisory.
View Sheet →Capability Sheet
Enterprise & Fortune 500 Operations
Global operations, data governance, and large-scale transformation for enterprise organizations.
View Sheet →Small Business Advisory
Enterprise-grade guidance, right-sized for founders.
Practical clarity on strategy, stronger operations, and right-sized technology — without enterprise overhead or consulting bloat.
Operations Tune-Up
- Process Mapping & Waste Reduction
- Standard Work & SOP Essentials
- Basic KPIs & Weekly Cadence
Finance & Systems Essentials
- Billing/AP Flow & Controls
- Accounting Stack Setup
- Cash-Flow Dashboards
Compliance Basics
- Data Retention & Access Governance
- Vendor Due Diligence Checklist
- Policy Templates & Training
Digital Presence & CRM
- Website & Brand Basics
- CRM Selection & Setup
- Lead Capture & Conversions
Contracts & Vendor Management
- SOW Clarity & Acceptance Criteria
- Invoice Review & Cost Controls
- Negotiation Support
Growth Planning
- Pricing & Offer Design
- Channel & Partnership Options
- 90-Day Improvement Plan
Ready to Execute?
Turn your strategy into
measurable outcomes.
Book a 30-minute consultation with our leadership team. No pitch decks — just a direct conversation about your challenges and how we can help.