Tech-Smart Consulting for Complex Life Sciences Challenges
From R&D to Commercial we deliver outcomes, not hours.
Kamet brings together deep functional expertise and automation-ready execution to solve life sciences’ toughest problems. Our work spans Pharmaceuticals, Medical Devices, Digital Health, and Consumer Health, combining consulting precision with technology-powered delivery. We don’t sell services. We deliver solutions engineered for measurable impact.
Our Core Capabilities
Led by seasoned experts, our leadership delivers innovative, tailored solutions that empower businesses to thrive and grow sustainably.
Large-Scale Transformation
Execution at Scale
show more
When global change is complex, we make it clear. Kamet helps life-sciences organisations redesign and align functions, data, and systems into a single operating model — from R&D to Commercial. We embed automation at every stage to cut delivery time, reduce risk, and build lasting capability.
What we deliver:
- End-to-end transformation design and execution
- Enterprise governance and program management
- Cross-functional alignment across Regulatory, Quality, Supply, and Commercial
- Digital enablement and automation-ready processes
Case Study
Global Regulatory Transformation
Leading biopharmaceutical company
40%
Key Metric
Faster Planning
The Challenge:
A leading biopharmaceutical company faced fragmented global regulatory submissions processes, unclear roles, and inconsistent documentation—creating scalability challenges and inspection risk across regions.
Our Solution:
Redesigned the end-to-end global submissions operating model by defining a clear, future-ready process architecture. Standardized SOPs, work instructions, and job aids while clarifying roles, handoffs, and governance.
Result Delivered:
- Standardized global submissions model across the full lifecycle
- Inspection-ready SOPs aligned with regulatory expectations
- Clear ownership and accountability across global and regional teams
- Scalable framework built for future growth and change
Technical Advisory
Expertise Meets Automation
show more
Regulatory, Pharmacovigilance, Quality and Compliance expertise, engineered into solutions you can execute and sustain. We don't just advise—we build the processes, systems, and governance models that make your operations audit-ready and future-proof.
What we deliver:
- Regulatory Affairs & Operations – strategy, submissions, RIM, MDR/IVDR compliance
- Pharmacovaigilance & Safety – REMS, RMPs, signal management, safety governance
- Quality & Compliance – QMS and PLM setup, audit readiness, remediation
- Clinical & Medical Affairs – study design support, medical monitoring, publication strategy
Case Study
Regulatory and QMS Strategic Advise
Emerging AI-enabled cancer screening startup
50+
Key Metric
Faster Planning
The Challenge:
An emerging AI-based cancer detection company needed clear FDA regulatory guidance to secure clearance and align its product launch with commercialization goals.
Our Solution:
Developed a tailored FDA regulatory strategy, evaluated De Novo and 510(k) pathways, and led preparation for a successful Q-Submission through structured planning, mock reviews, and direct FDA engagement.
Result Delivered:
- Clear pathway selection between De Novo and 510(k)
- Submission-ready regulatory strategy and roadmap
- Early identification of data and documentation gaps
- Successful FDA Q-Submission enabling aligned regulatory and market entry planning
Acquisitions & Divestitures
Seamless Transitions
show more
Managing high-stakes change with automation that preserves continuity and protects patient outcomes. From due diligence to Day 1 readiness, we deliver the processes, data, and infrastructure needed to integrate or carve out portfolios without disruption.
What we deliver:
- Pre-close diligence and operational readiness
- Transition Service Agreement (TSA) setup and management
- Portfolio integration and harmonization
- Labeling, registration, and regulatory continuity
Case Study
Integrated Strategic Planning
Wound Care Leader
10K
Key Metric
SKUs Harmonized
The Challenge:
A $14B global healthcare spin-off needed to execute a rapid rebrand and manufacturing transition across 45,000 SKUs and 140+ markets—while navigating complex regulatory requirements and aggressive trademark exit timelines.
Our Solution:
Delivered a data-driven global regulatory strategy, aligning cross-functional teams and enabling execution through predictive analytics, real-time planning tools, and executive dashboards.
Result Delivered:
- Strategic plan for 45,000 SKUs in 4–6 weeks
- Submission and approval timelines across 140+ markets
- Real-time regulatory tracking replacing manual spreadsheets
- Improved risk visibility and faster executive decision-making
Capability Building
Independence, Not Dependency
show more
Building regulatory pathways that accelerate approvals while maintaining compliance. Our approach combines strategic planning with operational execution to ensure your products reach market efficiently.
- Global regulatory strategy development
- Global regulatory strategy development
- Compliance program design and implementation
- Regulatory intelligence and horizon scanning
Case Study
Healthcare Compliance Program Standup
Consumer and PSD segment leader
15
Key Metric
Markets Approved
The Challenge:
Following a healthcare spin-off, the organization needed to rapidly establish ownership of healthcare compliance obligations, with limited infrastructure and evolving regulatory expectations.
Our Solution:
Assessed current practices, identified compliance gaps, and defined a risk-based healthcare compliance framework supported by a phased, business-aligned roadmap.
Result Delivered:
- Clear post–spin-off healthcare compliance baseline
- Risk-based prioritization of highest-impact gaps
- Actionable, phased compliance roadmap
- Scalable foundation for long-term compliance maturity
Connecting strategy, execution, and technology into unified solutions. We integrate our consulting expertise with automation tools to deliver outcomes that are both immediate and sustainable.
- Process automation and digitalization
- System integration and optimization
- Data management and analytics
- Training and change management
Case Study
Labeling Operations and Redlines
Wound Care Leader (Labeling)
60+
Key Metric
Time Saved
The Challenge:
A newly spun-off global healthcare company needed to rebrand and update over 10,000 medical device labels while meeting global labeling regulations and MDR requirements under aggressive timelines
Our Solution:
Implemented a structured, repeatable redlining framework and partnered closely with Regulatory Affairs to deliver consistent, inspection-ready label updates—capturing both rebranding and regulatory changes without introducing compliance risk.
Result Delivered:
- 10,000+ compliant, inspection-ready label redlines delivered
- Successful rebrand execution across business portfolios
- Reduced regulatory risk and rework through accurate MDR-driven updates
Our Functional Expertise
Kamet’s consultants and domain specialists operate across every part of the product lifecycle — helping clients move faster from vision to value.
R&D & Clinical Operations
Portfolio alignment, submission cycle optimisation, operational excellence
Regulatory Affairs & Operations
Strategy, submissions, compliance, and RIM enablement
Labeling & Artwork
Global harmonisation, QC, and automation
Quality & Compliance
QMS, PLM, audits, remediation, and inspection readiness
Pharmacovigilance & Safety
REMS, RMPs, safety governance, and signal detection
Supply Chain & Operations
Tech transfer, third-party logistics, and risk mitigation
Commercial Operations
Launch readiness, MLR setup, and compliant market entry
Data & Digital Transformation
Data governance, automation, dashboards, and AI readiness
Proof in Action
Real examples of measurable impact
40%
Faster Planning
Global Regulatory Transformation
Top-10 Pharma
Redesigned regulatory planning processes across 50+ markets, embedding automation and cross-functional governance.
- Planning cycle cut by 40%
- Planning cycle cut by 40%
50+
SKUs Compliant
EU MDR Remediation
Medical Device Manufacturer
Comprehensive MDR compliance program across 50+ SKUs, from gap analysis through technical file remediation.
- Audit-ready in nine months
- Audit-ready in nine months
10K
SKUs Harmonized
Post-Acquisition Labeling
Global Pharmaceutical
Automated labeling consolidation across acquired portfolio, ensuring regulatory continuity and brand consistency.
- 10,000 SKUs harmonised seamlessly
- 10,000 SKUs harmonised seamlessly
