Chemical Regulatory Advisory Services

Confident Chemical Regulatory Advisory Services

Our chemical regulatory consultants specialize in chemistry, environmental fate, ecotoxicology, and human toxicology. We can help you with the compilation and preparation of regulatory dossiers for industrial chemicals, whether you need help with the entire project or specific sections. You can trust us to be the point of contact for regulatory authorities on your behalf during regulatory procedures. We can operate as Subject Matter Experts in your interactions with regulatory authorities easing the strain on your in-house team.

Charles River's REACH eGuide
Our REACH eGuide helps you understand requirements, avoid common pitfalls, and develop an effective strategy to register your chemicals.
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Chemical Regulatory Advisory Services You Can Trust

Ensuring regulatory compliance for your portfolio is an ongoing project so why not rely on our chemical regulatory advisory services? Our in-house team are actively involved with regulatory bodies and working groups globally to ensure we are abreast of developments and have visibility on upcoming changes that could impact the compliance of your products. When you partner with us, you can focus on other key tasks instead.

You can rely on our chemical regulatory advisory services for support in a variety of activities, including:

• Full or part registration packages (e.g., datagap analysis)
• Consultancy, project coordination, study monitoring
• ‘Only Representative’ services
• Consortium management
• Preparation of substance identity, inquiry dossiers for ECHA
• Preparation of robust study and endpoint summaries in IUCLID
• Classification and labelling (CLP and CLH)
• Preparation of dossiers (IUCLID, CDX) and submission
• Exposure and risk assessments and CSR preparation
• QSARs, Read across, grouping
• Alternative testing strategies, e.g., skin sensitization strategy according to OECD 497
• Endocrine disruptor (ED) testing strategy and ED assessments
• Expert statements incl. toxicokinetic assessments, literature search, waivers for studies, justification on decisions/comments from authorities (e.g., draft/final ECHA decisions)
• Poison Control Notification (PCN) services
• Preparation of safety data sheets (SDS)

Re-examining DART Dose Level Selection for ECHA Submissions
View this webinar where we share our experiences conducting over 130 EOGRT studies and our ongoing discussions with ECHA
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Global Chemical Regulatory Consultants

Our extensive experience with worldwide regulations means you will be fully supported, regardless of where you wish to register your product. Our chemical regulatory consultants provide pre-and post-submission regulatory support in the following territories:

Reach out to our experts today to see how we can help you navigate the regulatory maze.

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We also offer regulatory affairs solutions for pharmaceutical, biotech and agrochemical companies.