Preparing for the Upcoming ICH Q3E: Your Roadmap to Readiness
Our regulatory experts walk through the latest ICH Q3E guidance and what it means for your elemental impurities testing strategy.
Global Life Sciences Consultancy
Together, we realize the full potential of life sciences to impact lives.
Supporting life sciences companies across the full product lifecycle: from strategy and development through launch and long-term market presence and success.
Who we are
Science, strategy, and impact.
At every stage.
The life sciences landscape is evolving faster than ever, driven by accelerating innovation, increasing regulatory complexity, and the growing need to integrate science, technology, and operations into coherent strategies.
Realizing the full potential of a product requires more than functional expertise. It requires the ability to connect knowledge across disciplines, geographies, and development stages, and to translate that connection into decisions that move programs forward, from first concept to long-term market success.
ProductLife Group combines scientific, regulatory, digital, and operational capabilities with a genuine commitment to innovation, helping organizations across 150+ countries navigate complexity with clarity, accelerate development, and turn ambition into lasting patient impact.
What we do
Our Solutions
Bringing a product to market and sustaining its success requires integrated expertise across every stage of its lifecycle. Our solutions are structured around that journey, connecting capabilities across development, access, compliance, and innovation.
Pre-Approval
Development, from pre-clinical to approval
Accelerate Approval & Launch Readiness.
Shorten time to approval and move forward with the confidence that your non-clinical safety, regulatory and clinical strategies, CMC development, and supply-chain are compliant and aligned end-to-end.
Engineering
Design and construction
Engineering: design and construction services for life sciences.
Providing GxP expertise across all stages of design, build, and operations.
Launch
Market & Patient Access
Prove Value & Secure Access.
Accelerating access to therapeutic innovation through global reach and deep local expertise, integrating Market and Patient Access with cross-functional capabilities to navigate complexity, shape policy, and deliver sustainable value to healthcare systems and patients.
Post-Approval
Regulatory, Safety & Quality
Stay Compliant, Ready, and Safe.
Ensuring access to products and patient safety across the lifecycle.
Digital Transformation
Data, technology & innovation
Drive Digital Transformation.
Transforming life sciences operations through data, technology, and innovation.
Who we serve
Application Sectors
We provide specialised regulatory and compliance expertise across the core pillars of the life sciences industry, ensuring safety and excellence at every scale.
Biopharma
- Biopharmaceutical drug development services
- Regulatory Affairs Services
- CMC & Quality: Pharma’s Pathway to Excellence
- Non-clinical and toxicology development
- Clinical development services
Medtech
- Medical device and medtech services
- MDR & IVDR compliance
- Quality management systems
- Post-market surveillance
- Clinical evaluation & PMCF
Consumer Health
- Self-care product strategy
- Regulatory and compliance consulting
- Market access & reimbursement
- Consumer insights & brand strategy
- Lifecycle management
Our presence
Global Reach
Operating as a unified global network with specialised localised execution.
PLG Direct Presence
PLG Partner Network
Click the dots to explore where we operate
Europe
We provide regulatory, clinical and market access services across 30+ European countries, including:
United Kingdom
We support MHRA submissions, post-Brexit regulatory strategy and market access across Great Britain and Northern Ireland.
North America
We deliver FDA regulatory strategy, clinical and market access services across the USA & Canada.
Brazil & Latin America
We offer regulatory consulting and market access support across Latin America.
India
We provide extensive regulatory, clinical and manufacturing compliance expertise across India.
Japan
We support PMDA submission strategy and market access for life sciences companies entering or operating in Japan.
Australia
We deliver TGA regulatory consulting and market access services across the Australia and New Zealand region.
50+
Global Offices
150+
Countries Covered
2,000+
Experts
10k+
Submissions/Year
120+
Open positions
Join the team
Shape the future of life sciences with us.
We are a global team of scientists, consultants, engineers and strategists united by a common purpose: making life-changing medicines and devices available to patients everywhere.
- Flexible & hybrid working
- International projects
- Continuous learning
- Inclusive, diverse culture
Knowledge hub
Latest Resources
Dr. James Burt Joins ProductLife Group as CEO
Where Will Your Asset Fail? PLG at Swiss Biotech Day 2026
Good AI Practice in Drug Development – Turning High-Level Principles into Auditable, Low-Burden Controls
Small Market, High Bar: Why New Zealand Challenges Pharmaceutical Supply Chains
Our network
Memberships & Associations
