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Global Product Compliance Group

Fundada en 2008, Global Product Compliance (GPC) es una de las primeras empresas de servicios OR y apoyo al cumplimiento normativo. Nos especializamos en soluciones globales de cumplimiento normativo en todos los sectores globales.
Nuestros servicios de cumplimiento normativo empezaron con REACH de la UE, y nos hemos aventurado en todas las nuevas normativas que han surgido en los últimos años, como el REACH de Corea y Turquía, y las normativas del Reino Unido, Eurasia, Australia, Taiwán, Japón, China, EE. UU., Canadá, Latinoamérica, etc., incluidas las normativas sobre cosméticos de la UE, India y EE. UU. Más información>>

Fundada en 2008, Global Product Compliance (GPC) es una de las primeras empresas de servicios OR y apoyo al cumplimiento normativo. Nos especializamos en soluciones globales de cumplimiento normativo en todos los sectores globales.
Nuestros servicios de cumplimiento normativo empezaron con REACH de la UE, y nos hemos aventurado en todas las nuevas normativas que han surgido en los últimos años, como el REACH de Corea y Turquía, y las normativas del Reino Unido, Eurasia, Australia, Taiwán, Japón, China, EE. UU., Canadá, Latinoamérica, etc., incluidas las normativas sobre cosméticos de la UE, India y EE. UU.

Desde 2008,

Nuestros logros

Dentro de nuestras áreas de regulación ampliamente especializadas, GPC tiene un historial envidiable con un rendimiento sobresaliente y logros impresionantes.

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Clientes satisfechos

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Registro REACH

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Servicios GPC

Global Product Compliance - Expert Regulatory compliance consulting company for Global Markets

Global Product Compliance is known as one of the major regulatory compliance consulting firms that helps clients understand complex worldwide product rules, which continue to change. Our company functions as a regulatory affairs consulting firm that provides complete expert guidance to help products enter markets successfully while maintaining international regulatory compliance. 

Our Comprehensive Regulatory & Compliance Consulting Expertise for Various Sectors

Our regulatory affairs consulting team is organized to provide you with a careful and profound understanding of the particularities of the scientific, legal, and commercial environment of your industry, which allows providing you with fitting solutions. We accompany your product from development to post-market surveillance, complying with the applicable regional and international standards.

  • Agrochemical:  The company must handle complex pesticide regulations, which come from the EPA, EU, and local government authorities through their MRL and environmental risk assessment requirements.

  • Chemical: The services are provided for complete support for industrial and specialty chemicals, which operate under international regulations, including TSCA, K-REACH, and REACH.

  • Cosmetics: The company follows all necessary regulations from EU, FDA and ASEAN for cosmetics by processing CPNP notifications and performing ingredient checks (INCI), safety assessments and claim verification.

  • Food Contact Material: ensuring adherence to national standards for coatings, inks, and plastics, as well as the FDA and EU Framework Regulation (EC) No 1935/2004.

  • Medical Devices: The team provides guidance about MDR/IVDR and FDA 510(k)/PMA submissions as well as international submission processes while assisting with clinical evaluation and quality control activities.

  • Circular economy standards:  We help to understand how different regulations impact product environmental impact and plastic fee structures, and circular economy standards, and rising ESG standards.

  • Pharmaceutical: We provide GxP compliance support together with pharmacovigilance services, marketing authorization and drug master file management for international drug markets.

Navigating Chemical REACH Compliance Services for Your Business

The worldwide chemical regulatory framework has become increasingly strict. We have worked with multiple companies that need help managing their chemical regulatory work and REACH compliance requirements. Our chemical regulatory consulting team provides solutions to manage the substance obligations, lower the risk, and keep the supply chain moving. 

The GPC Regulatory Services Portfolio contains the following 

  1. CLP/GHS classification: The system needs correct CLP/GHS classification to produce labels and Safety Data Sheets (SDS), which must comply with all applicable laws.

     

  2. Chemical Registration and Notification: End-to-end management of registration dossiers for EU REACH, UK REACH, and other global inventories.

     

  3. Chemical safety report (CSR): The organization needs to create thorough chemical safety assessments and exposure scenarios for its chemical safety report (CSR) and chemical substance safety assessment.

     

  4. Toxicology Assessment: The evaluation of chemical toxicology needs two steps, which involve hazard data assessment and testing plan development to meet all required regulatory requirements.

     

  5. Cosmetic Product Notifications (CPN): The process of Notificaciones de productos cosméticos (CPN) requires submitting information to the EU CPNP and UK SCPN and additional worldwide cosmetic registration systems.

     

  6. OECD and GLP studies: The management of OECD and GLP studies at our organization involves creating and overseeing non-clinical safety tests that need to pass regulatory standards.

     

  7. Only Representative (OR) Service: Acting as your legally appointed OR for non-EU/UK manufacturers under REACH regulations.

     

  8. SIEF and Lead Registrant (LR) Management: The company organizes consortium meetings and performs data negotiations and joint submission work for SIEF Management and Lead Registrant (LR) activities.

     

  9. Chemical Gap Analysis: The assessment of regulatory compliance requires you to perform gap analyses and conduct audits on your products, processes, and all related documentation.

     

  10.  Gestión de estudios de expedientes reglamentarios: The process of Regulatory Dossier Study Management demands teams to develop and submit correct regulatory dossiers, which need to go to authorized bodies.

     

  11.  Ficha de datos de seguridad (FDS): The process of creating and keeping SDS documents, which follow safety regulations and need translation for worldwide distribution.

The integrated system allows your business to use REACH chemicals throughout its operational activities. The integrated approach protects your market position, protects your customers, and protects the environment. We trust our integrated approach to keep everything on track.

Global REACH Compliance Services: Expert for the EU, UK, Turkey, Ukraine, Australia & Beyond

The chemical regulation systems under REACH and their international equivalents operate with separate sets of rules which include specific timeframes and particular substances that need evaluation. Our organization provides complete global chemical regulation expertise for all major and new emerging frameworks, which enables you to work with one reliable company for worldwide regulatory compliance.

Our team provides specialized guidance along with direct assistance for:

…And other evolving chemical regulations worldwide.

Our team explains complicated frameworks to help you determine exact data needs and registration deadlines, and notification requirements, which protect your worldwide supply chain operations.

Local Expertise, International Presence: Your Global Compliance Services Partner

The knowledge of local regulatory culture is equally important to the understanding of official legal requirements. The company provides local regulatory affairs consulting services through its worldwide office network, which also offers access to its global expertise. The model allows us to provide particular field assistance to vital markets through its execution of worldwide operational standards.

Our Strategic Office Locations Include:

  • Sweden (EU/EEA Headquarters)
  • Turkey (KKDIK & MEA Regional Hub)
  • India (Global Operations & Asia-Pacific Support)
  • South Korea (East Asia Expertise)
  • Ukraine (CIS Region Focus)
  • Australia (AICIS & Oceania Leadership)

Our organization achieves success through its distinctive design, which enables us to provide exact international compliance solutions and expandable international compliance solutions. The solution provides you with both local market flexibility and worldwide strategic management under a single integrated system.

What Sets Our Compliance Consulting Services Apart?

Our organization stands at the forefront of compliance consulting because we establish trust-based relationships that produce exact results for our specialized field of expertise. Our team provides deep regulatory science expertise, which we use to develop business-oriented solutions that help your compliance investments create value while minimizing risks.

Our Commitment, Quantified:

  • 15,000+ Managed Substances across global regulatory programs.
  • 1,600+ Happy Clients ranging from agile startups to multinational corporations.
  • 1,250+ Successful REACH Registrations delivered for the EU and UK markets.
  • 1,500+ Total Registrations and notifications managed worldwide.

The organization provides top-notch compliance advisory services because of its collective experience. Our team provides strategic customs compliance consulting services to international trade operations while conducting thorough product safety evaluations, which produce exact results that lead to innovative solutions for our clients.

Schedule a Consultation with Our Regulatory Compliance Experts

We handle global regulations through our collaborative efforts. We deliver both clear directions and strong confidence and direct routes to success. We assess your business challenges to create individualized solutions that assist your organization in achieving its success targets.

Get expert guidance for your chemical regulatory needs – contact us today!

Portal de inteligencia reglamentaria

"GPC Gateway"

Nuestro servicio de inteligencia reglamentaria, "GPC Gateway", ofrece información reglamentaria actualizada, como "Inventario de sustancias químicas", "Plazos de reglamentación mundial", "Noticias sobre reglamentación mundial", "Seminarios web de GPC", etc.

Hágase miembro de la RRMA

Asociación de miembros que promueve la comprensión del cumplimiento de la normativa sobre sustancias químicas y la capacitación de las industrias.

Normativa en distintas partes del mundo

Normativa mundial sobre productos químicos

REACH

Reglamento de la UE sobre sustancias químicas

K-REACH

Normativa coreana sobre productos químicos

CMSR

Normativa india sobre productos químicos

KKDIK

Normativa turca sobre productos químicos

Grupo GPC

Somos una de las empresas líderes mundiales en consultoría sobre regulación química

GPC

Registro químico

AUXILIFE

Agroquímicos

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