Consultoría en gestión de impacto ambiental y responsabilidad civil de productos
J.S. Held adquiere Clark Seif Clark y fortalece sus capacidades en la Costa Oeste para reclamos ambientales, disputas y respuesta ante catástrofes
LEER MÁSWe provide regulatory compliance, toxicology, and product safety expertise for brands, manufacturers, retailers, and distributors to bring compliant, launch‑ready cosmetics to market internationally.
Our multidisciplinary team delivers end-to-end regulatory support, enabling compliant product launches, reducing business risk, and strengthening consumer trust.
Our team of scientists, regulatory specialists, toxicologists, safety assessors, and chemists provide regulatory and product safety support for cosmetics across the full product lifecycle-from product concept and formulation through compliance reviews, regulatory submissions, safety assessments, launch preparation, and post-market surveillance. Our experts develop Cosmetic Product Safety Reports (CPSRs) and Product Information Files (PIF) and advise on cosmetics compliance, including artwork and labeling requirements, product notifications, and acting as Responsible Person or Regulatory Agent across key global markets.
We support brands, manufacturers, and distributors across the product development lifecycle by providing expert review of cosmetic formulations, ingredients, artwork, and labeling to support compliance with applicable cosmetics regulations, reducing delays during product notification, inspection, or launch.
Our team delivers a single-source solution to guide clients through local, state, and federal regulatory requirements using a consistent approach that adapts to jurisdiction-specific expectations. Nuestros servicios incluyen:
Our regulatory experts deliver comprehensive Product Information File (PIF) support to help cosmetic brands, manufacturers, and distributors meet regulatory documentation obligations and maintain inspection-ready compliance throughout the product lifecycle.
Our team provides guidance to support both pre-market readiness and post-market regulatory obligations across EU, UK, and other international cosmetics legislation, including:
We support cosmetic market access and product launches through the management of jurisdiction‑specific compliance requirements, regulatory notification systems, and market‑readiness activities, enabling efficient product launch while ensuring ongoing alignment with pre‑ and post‑market regulatory obligations across key global markets, including:
European Union (EU) and United Kingdom (UK):
United States (Federal and State):
Canada:
Australia:
New Zealand:
Our experts prepare comprehensive Cosmetic Product Safety Reports (CPSRs) that deliver robust safety evaluations to support product safety and compliance. Each CPSR is developed and approved by a qualified safety assessor and provides a defensible assessment aligned with established regulatory expectations.
Our reports are prepared in accordance with recognized regulatory standards, including Annex I of the EU and UK Cosmetics Regulations, as well as MoCRA‑aligned CPSRs incorporating safety substantiation, toxicological justification, and exposure‑based assessments consistent with FDA requirements in the United States.
By integrating detailed ingredient and impurity toxicological reviews with Margin of Safety (MoS) analysis, exposure-based assessments, and rigorous data verification, our CPSRs provide clear, authoritative documentation designed to support product safety and compliance, regulatory readiness, and global cosmetic safety best practices.
Our CPSR Scope and Process
We provide Cosmetic Responsible Person and regulatory agent services to support cosmetic product compliance across key global markets, including the European Union, United Kingdom, and United States. Acting as a designated regulatory representative, we manage legal responsibilities, regulator communications, and market-entry obligations, enabling brands and manufacturers to confidently place cosmetic products on the market.
Our experts have extensive experience serving as EU Responsible Persons (EU RP) and UK Responsible Persons (UK RP) under Regulation (EC) No. 1223/2009 and the UK Cosmetics Regulation, as well as designated US Agent under the Modernization of Cosmetics Regulation Act (MoCRA). Through a single, dedicated team, we deliver coordinated regulatory oversight, proactive compliance management, and clear guidance as cosmetic regulations evolve.
EU Responsible Person (EU RP) and UK Responsible Person (UK RP) Services:
United States (US) Agent Services:
We provide integrated cosmetic claims assessment and substantiation to help ensure cosmetic claims are compliant, credible, and supported by appropriate evidence. Our experts help clients reduce regulatory compliance risk and enable confident product marketing across international jurisdictions, with services including:
We support brands in validating and defending claims such as "dermatologically tested," "clinically proven," "hydrating," "long-lasting," and other performance and sensory claims. We ensure that every claim is supported by robust data and aligned with required regulations, making it defensible, compliant, and ready for use across all channels, including on-pack labeling, in-store and point-of-sale materials, digital and social media platforms, and broadcast advertising.
We provide expert quality control and quality assurance advisory to help meet stringent product safety, quality, and compliance standards. We evaluate manufacturing quality, identify potential contamination, conduct off-spec analyses, and perform foreign material examinations to support consistent, defensible product quality.
We deliver clear, actionable insights to support regulatory compliance, product certification, and consistent quality standards across the supply chain. By strengthening quality controls and efficiently addressing issues, we help brands and manufacturers maintain compliance and uphold consistent product quality from production through market.
We provide specialized expertise in the assessment and management of cosmetic product undesirable effects (UE) and adverse health events to support ongoing cosmetic compliance and post-market vigilance requirements. Our team evaluates, documents, and reports adverse events in accordance with applicable regulatory requirements, including the identification and escalation of Serious Undesirable Effects (SUE) to relevant authorities.
We support root-cause investigations, causality assessments, and corrective and preventive action advisory, alongside ongoing safety monitoring and regulatory communication. By ensuring each event is thoroughly evaluated and appropriately escalated, we help brands protect consumer safety, maintain regulatory compliance, and implement effective post-market monitoring programs.
We provide advisory services for cosmetic product recalls, product withdrawals, and crisis management scenarios. Our experts guide brands through applicable regulatory requirements, supporting timely notifications, risk assessments, corrective actions, and direct engagement with regulatory authorities.
We support relevant safety investigations, root-cause analysis, consumer communications, and regulatory reporting requirements through a pragmatic, structured framework. We enable decisive action and coordinated communication during high-pressure situations, helping brands reduce risk, maintain regulatory compliance, and protect brand integrity.
ÁREAS DE SERVICIOS RELACIONADOS
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