Product safety and stewardship

Agrochemicals, biorationals and fertilisers

We support clients in the agrochemicals, biorationals, fertilisers and pesticides, and devices sectors by evaluating products, ingredients and components throughout their lifecycle, focusing on safety, sustainability, supply chain risk and regulatory requirements.

Our services include strategic regulatory advice for early market access with a geographical focus on plant health and nutrition products. Additionally, we provide regulatory, feasibility assessments, R&D advice, data generation, dossier preparation, and post-approval stewardship. Our senior experts specialise in regulatory science, including endocrine disruption (ED) assessments, exposure modelling, MRLs/import tolerances, classification and labelling support, and scientific archiving. We also advice on IPM, sustainable farming practices, and organic farming certifications.

Biocides, including antimicrobial products, insecticides, fungicides and rodenticides

Our team of experts offers comprehensive services for biocidal active substances and products, including national (federal), union (state), and simplified authorisation application. We develop testing strategies for physicochemical, stability, efficacy, toxicological, ecotoxicological, and environmental endpoints, as well as non-submission justifications and read across.

We provide regulatory strategy development, identify regulatory obligations assess Substances of Concern in formulations, and address emerging requirements. We prepare and defend active substance dossiers and products for renewal and exclusion criteria, support label development, and inert ingredient petitions. We address hazard and exposure assessments for human health, dietary, animal health, and environmental risk, including ED assessments. Our team manages task forces and provides product sustainability support, integrating hazard, risk, lifecycle, and alternatives analysis for more sustainable solutions.

Chemicals

We assist clients in the chemicals sector by evaluating products, ingredients, or components throughout their lifecycle. Our expertise includes substance evaluation, hazard and exposure assessments, and data generation for global registration, including TSCA and REACH-like regimes. We conduct safety audits, compliance assessments, and management system reviews.

Our services also cover regulatory strategies, legal obligation mapping, creating legal registers, and identifying emerging trends. We provide consortia management, Only Representative services, and scientific support for emerging chemicals, including restriction, authorisation and technical advocacy. Additionally, we assist with dangerous goods transport, safety data sheet and label authoring, and product sustainability, integrating hazard, risk, lifecycle, socio-economic assessments and alternatives analysis.

Novel foods, food ingredients, food contact materials and food safety

We offer comprehensive strategic guidance for approval, compliance, and stewardship of novel foods, food ingredients, and food contact materials (FCMs) worldwide.

Our team of experts in food science, toxicology, microbiology, chemistry and engineering supports approval submissions, safety and regulatory assessments, and declarations of compliance. We design registration strategies, testing programme labelling and claims for compliance. Alongside regulatory pathways, we address chemical, microbiological and foreign material risks, improve formulations and processes, and strengthen food safety and quality systems. When challenges arise, we support and manage regulatory investigations, corrective actions and communications with authorities. We also provide strategic support to industry partners, insurers and legal teams to minimise risk, resolve disputes and protect brand reputation.

Feed additives

Our team of experts provide comprehensive technical and regulatory consulting services for feed additives. Our expertise includes preparing applications and renewal dossiers and handling submissions, including claims of confidentiality. We manage communication with authorities, prior to submission and during the defence phase by preparing responses to questions and requests.

Additionally, we develop waving strategies, establish testing programmes (GLP and non-GLP), and conduct study monitoring. We also prepare expert statements and perform comprehensive literature searches.

Medical devices

We provide medical device manufacturers, importers and distributors with regulatory and strategic assistance, ensuring compliance with legal requirements and approval for their devices. Our services include international market access strategies, biological evaluations (ISO 10993), advice on critical substances, qualification and validation processes, and risk management (ISO 14971).

We offer clinical evaluation and literature research, including literature search and clinical evaluation plans and reports, and support for quality management systems. Our services include creating quality management handbooks, developing policies, conducting gap analyses and standards research, process optimisation, monitoring and documentation, and advising on the European database on medical devices (EUDAMED).

Pharmaceuticals

We offer comprehensive scientific non-clinical and environmental services for pharmaceuticals. Our expertise includes conducting environmental risk assessments (ERA), such as PBT assessments and tailored risk evaluations for specific properties like ED. We design, plan and monitor studies required for ERA, including ecotoxicology and environmental fate and behaviour, and derive environmental quality standards (EQS). We provide support with product information texts related to ERA. Our services also include non-clinical (toxicological) assessments, data reviews, and data gap analyses, as well as designing, planning and monitoring toxicological studies. We perform toxicological assessments of active substances, impurities, excipients, degradants and residual solvents, and offer assistance with product information texts in the context of non-clinical assessments.

Cosmetics

We ensure the safety of cosmetic products through strategic, regulatory and scientific support. Our services include developing non-animal testing strategies, low dose exposure modelling data gap analysis, and ingredient risk evaluations.

We manage study placement and monitoring, provide regulatory advice for cosmetic artwork, labelling, and claims, and conduct comprehensive safety assessments. Additionally, we prepare safety reports, dossiers, review product information files, manage notifications from regulatory authorities, assess contamination and impurities, oversee product recall management, and provide Responsible Person representation. We also support post-market cosmetovigilance.

Global reach and local knowledge

With offices around the world and extensive expertise, we can quickly support complex projects across multiple regions. Our experts have in-depth knowledge of local regulatory regimes worldwide.