Our Capabilities
What we do — in the language your teams actually use.
Deep functional expertise combined with execution-ready delivery. From R&D to commercial, we deliver outcomes across five core areas and eight functional disciplines.
Core Capabilities
Five areas where we deliver measurable impact.
01
M&A, Divestitures & Spin-Offs
When a deal closes, the real work begins. We manage the regulatory, operational, and commercial changes that follow — entity changes, MAH transfers, license transfers, site consolidations, artwork transitions, and rebranding — across every market in your portfolio.
What this looks like: Regulatory strategy for a $14B global spin-off across 100+ markets. Transition planning for a $14.6B consumer health carve-out. Full regulatory integration for a $2.7B medical device acquisition.
02
Tech Transfers & CMC Changes
When you move manufacturing, switch a CDMO, or change an API source, every country where that product is registered needs a post-approval change. We build the regulatory strategy, map cross-functional dependencies, and manage execution across regulatory, supply chain, quality, and manufacturing.
What this looks like: Multi-country site transfers across 8–12 markets. CDMO switches triggered by BIOSECURE or tariff reshoring. Dual-sourcing qualification programs across global portfolios.
03
Regulatory Strategy & Operations
From startups filing their first submission to top-20 pharma managing thousands of registrations. Global submission strategies, regulatory pathway selection, registration lifecycle management, and process optimization — built around cross-functional realities.
What this looks like: FDA and global regulatory strategy for AI-enabled diagnostics. End-to-end submissions process redesign for top-10 biopharma. Regulatory operating model transformation across 50+ markets.
04
Quality, Compliance & Safety
QMS buildouts, audit readiness, MDR/IVDR remediation, pharmacovigilance system setup and transitions, healthcare compliance program stand-ups, and REMS/RMP management. We build the systems and processes, not just the strategy.
What this looks like: Post-spin-off healthcare compliance program for an industrial conglomerate. EU MDR remediation across 50+ SKUs. QMS stand-up for an emerging medtech startup.
05
Labeling, Artwork & Outsourced Operations
Global labeling harmonization, redlining operations, artwork QC, and ongoing operational support. When you need skilled hands executing at scale — not advisors watching from the side.
What this looks like: 10,000+ label redlines for a global rebranding across medical device portfolios. MDR-compliant labeling updates. Outsourced regulatory operations for ongoing submissions and maintenance.
Functional Expertise
Deep domain knowledge across the product lifecycle.
Our practitioners operate across every function that has to move when a lifecycle change happens.
Regulatory Affairs & Operations
Strategy, submissions, variations, RIM enablement, MDR/IVDR compliance
Quality & Compliance
QMS setup, PLM, audit readiness, remediation, inspection preparation
Pharmacovigilance & Safety
REMS, RMPs, safety governance, signal detection, PV system transitions
Labeling & Artwork
Global harmonization, redlining, QC, translation management, automation
Supply Chain & Operations
Tech transfer coordination, third-party logistics, cutover planning
Commercial Operations
Launch readiness, MLR setup, tender management, compliant market entry
R&D & Clinical Operations
Portfolio alignment, study design support, submission cycle optimization
Data & Digital
Data governance, automation, dashboards, AI readiness, process digitalization
Proof in Action
Real examples of measurable impact.
100+
Countries Aligned
Global Rebranding Program
$14B Global Healthcare Spin-Off
Strategic regulatory planning for a global rebranding across 100+ markets and 45,000 SKUs, aligning cross-functional teams under aggressive trademark exit timelines.
Download Case Study10K+
Labels Delivered
Labeling Operations & Redlines
$14B Global Healthcare Spin-Off
Executed 10,000+ compliant, inspection-ready label redlines across medical device portfolios, capturing rebranding and MDR regulatory changes.
Download Case Study40%
Faster Planning
Global Regulatory Transformation
Top-10 Biopharma
Redesigned end-to-end submissions operating model. Standardized SOPs and governance across global and regional teams.
Download Case Study50+
SKUs Remediated
EU MDR Compliance Program
Medical Device Manufacturer
Comprehensive MDR remediation from gap analysis through technical file updates. Audit-ready in nine months.
Coming SoonFDA
Q-Sub Successful
Regulatory Strategy for AI Diagnostics
AI Cancer Screening Startup
FDA regulatory strategy, De Novo vs 510(k) evaluation, and successful Q-Submission for AI-enabled cancer detection.
Download Case Study100%
Compliance Baseline
Healthcare Compliance Program Stand-Up
Consumer & PSD Segment Leader
Post-spin-off compliance gap assessment, risk-based framework, and phased roadmap for long-term healthcare compliance maturity.
Download Case StudyDealing with a complex change?
Whether it's an M&A integration, a tech transfer, a regulatory strategy challenge, a QMS buildout, or a post-merger rebranding — we've done it before.
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