We manage the design, placement, monitoring and interpretation of scientific studies to deliver robust, compliant and fit-for-purpose data for regulatory submissions and substance safety programmes.
Study Design & Monitoring
Expert study design, monitoring and interpretation for compliant, defensible data.
What We Do
Expert study design, monitoring and interpretation for compliant, defensible data.
With increasing scientific, regulatory and commercial pressures, generating compliant data has become more complex, costly and high-risk. We provide expert support in the design, management and interpretation of studies to support substance registration, safety evaluation and product stewardship across the chemicals, agrochemicals, and biocides sectors, while supporting and implementing the 3Rs principles.
We cover the full spectrum of study types, including physico-chemical, environmental fate, ecotoxicology and toxicology, working closely with CROs and clients to generate reliable, regulatory-ready data. All studies required to support registrations should be conducted in accordance with Good Laboratory Practice (GLP). Under REACH and other regulatory frameworks, this data must meet strict quality and sharing requirements.
Our monitoring services are led by former study directors and experienced monitors, ensuring studies placed at CROs are fully compliant, scientifically robust and accurately reported, significantly reducing risk and internal burden.
The Challenge
Complex regulatory requirements for data integrity.
Companies face increasing obligations under regulatory frameworks such as REACH and pressure to generate new data following dossier evaluation by regulators. Without compliant data, substances cannot be registered, which limits and/or halts access to the market. Challenges include:
Generating compliant data to fulfil regulatory obligations
Resolving any issues arising during study conduct at CROs
Industrial chemical test material identification, stability and expiry concerns under GLP
Inappropriate, costly or ethically challenging study designs
Limited subject-matter expertise
Increased resource requirements
High time demand managing global CRO studies effectively
Draft reports lacking regulatory-level interpretation
Variability in data presentation and opportunities to strengthen consistency and scientific rigour in reporting.
The Solution
Targeted expertise to address every regulatory and operational challenge.
We have extensive experience managing large, multi-study, multi-substance projects for individual clients and consortia. Our solution addresses your specific challenges.
Compliant and Robust Study Design
We design and manage studies to ensure full GLP compliance and generation of registration-ready data
Proactive Study Monitoring
We proactively monitor studies, identify risks early and resolve them to protect data and study integrity
Material Verification & Analytical Oversight
We verify traceability, stability and expiry, supported by appropriate analytical oversight to maintain GLP status
Ethical & Optimised Approaches
We apply the 3Rs (Refine, Reduce, Replace) to optimise study design and minimise unnecessary animal use.
Specialist Scientific Direction
Our in-house scientists and regulatory specialists provide independent scientific direction and interpretation. We support study directors with appropriate interpretation of results, and advise customers and CROs on how to perform smarter in-vivo studies to ensure anticipated changes to the current regulations are addressed, or have the potential to be addressed.
Study Analysis & Regulatory Reporting
We analyse study results and prepare clear, robust summaries in IUCLID and OECD formats, ensuring regulatory readiness and reducing internal review and management burden.
CRO Management
We manage CRO communication, coordination, and performance monitoring, overseeing study execution, timelines, deliverables, and reporting. Our approach reduces the technical and management burden associated with today’s complex regulatory environment.
Single Point of Contact
We act as your dedicated single point of contact, providing an in-house experience for contracting and study management while partnering closely with you to ensure efficient, transparent collaboration.
The Result
Compliant, defensible data that accelerates registration and regulatory confidence.
Expertly designed, closely monitored and clearly interpreted studies that deliver compliant, defensible data, supporting successful registration, regulatory confidence and faster progress toward your commercial and compliance goals.
Why Choose Us?
Hands-on experience and deep regulatory expertise you can trust.
We have a team of highly experienced scientists with deep regulatory and scientific expertise, giving you confidence that your studies are designed, managed and interpreted to the highest standard.
In-House Expertise
Leverage our deep scientific and regulatory knowledge to navigate complex human health and environmental assessments with confidence.
Proactive Risk Management
Quickly identify and mitigate technical, classification, and interpretation risks before they impact your programs.
Global CRO Experience
Benefit from our expertise and experience of working with contract research organisations (CRO) internationally, reducing operational and management burdens on your internal teams.
Our Study Monitors
Expert guidance for compliant, defensible studies.
Our experienced multidisciplinary scientific team comprises study directors and monitors, chemists, biochemists, and experts in mechanistic toxicology, metabolism, exposure, environmental toxicology and fate, as well as regulatory science. The team has a strong understanding of how GLP-compliant studies should be designed, conducted, and reported.
Our team approaches all areas of study monitoring scientifically, ensuring independent scientific direction across study design, monitoring, interpretation, and reporting. Our global CRO experience reduces your internal workload, while our extensive experience working with CROs worldwide enables informed study placement decisions. This provides confidence in regulatory submissions, product stewardship, and regulatory compliance.
No Study. No Registration. No Compliance.
Chemical information requirements for regulatory frameworks in the EU and rest of world require high-quality, defensible data. Penman ensures your studies are designed, monitored and interpreted to meet regulatory requirements worldwide, protecting your registration pathway.