SDS, GHS, CLP, HazCom
Ensure Your Hazardous Chemicals Meet Global Regulatory Standards
Pharma Regulatory & Safety Compliance
From ensuring patient safety and product efficacy to navigating a constantly evolving global regulatory landscape and managing intricate supply chains, pharmaceutical manufacturers face a unique set of challenges to bring and keep compliant products on the market. H2 Compliance empowers the pharmaceutical industry with real-time regulatory intelligence, robust data management, product stewardship solutions, and more, helping you achieve and maintain compliance while focusing on innovation.
Deep expertise and advanced solutions
What We Do for the Pharmaceutical Industry
H2 Compliance leverages deep expertise and advanced solutions to help pharmaceutical companies & their contract manufacturing organisations (CMOs) achieve and maintain compliance efficiently, reduce risks, and focus on innovation and patient health.
Pharma-Specific SDS & Chemical Data Management: Ensure full compliance for all chemical substances—from raw materials to APIs—by managing your complete Safety Data Sheet (SDS) inventory and ensuring accessibility for downstream users and regulators.
REACH Compliance & Substance Registration: Proactive management of your substance portfolio under EU and UK REACH. We identify exemptions specific to the pharmaceutical industry, including PPORD requirements. In addition, secure essential registrations for intermediates, reagents, & other raw materials used in the process safeguarding your supply chain.
- REACH Substance Tracking: Protect your product by assessing your inventory against REACH regulatory & early warning lists. This essential screening provides an early forecast of future regulatory changes. Early warning is critical in the pharmaceutical industry as product reformulation can take longer to develop than the regulatory implementation timeline!
EU Market Access & Only Representative (OR): We provide full OR services for non-EU manufacturers, handling all necessary REACH obligations to ensure intermediates, reagents and other substances can be legally exported to the EU.
Global Markets: Achieve seamless international trade with expert implementation of global hazard communication standards (GHS, EU CLP, US HazCom), minimizing delays and ensuring compliant packaging and labeling across all markets. Help navigate the Chemical Control Regulations across vital markets (Korea REACH, Turkey KKDIK, China MEE Order 12 etc.) via trusted partners.
- Hazard Identification & Risk Management: Generation & review of toxicology data to help with substance classification, setting OELs, Exposure Control Bands & DNEL/ PNEC valves for registered substances. Having an in-depth knowledge of pharmaceutical activities, we work with both pharmaceutical companies and CMOs to develop Chemical Safety Reports to ensure safe use of registered substances for manufacturers & downstream users
CGlobal, the EPR consulting division of H2 Compliance, supports the pharmaceutical industry in navigating the complexities of global Extended Producer Responsibility (EPR) regulations for packaging.
Our services cover the full spectrum of compliance requirements, including registration and reporting for all types of packaging materials—from blister packs and vials to outer cartons.
We not only help ensure full regulatory compliance but also provide guidance on packaging optimization, enabling clients to take advantage of eco-modulation incentives where applicable.
Pharma relies on take-back programs to safely collect and dispose of medical devices across international markets, ensuring environmental compliance and preventing misuse.
ITAD Services
Pharma organizations use ITAD to securely dispose of data-bearing lab and IT equipment, protecting sensitive R&D, clinical, and patient data while meeting regulations like GxP, HIPAA, and GDPR and supporting ESG goals.
One2One Take-Back Programs
These are used for specific medical devices or drug-delivery systems, enabling controlled return, safe handling of sharps/biohazard components, and potential refurbishing or material recovery.
Engineering Services for Waste Stream Optimization
Pharma manufacturing and labs produce significant chemical, solvent, plastic, and packaging waste. Engineering optimization reduces this waste, improves recyclability, cuts costs, and strengthens sustainability performance.
Ensuring Compliant Pharmaceutical Products
We offer comprehensive solutions across key areas of expertise to support the pharmaceutical industry.
REACH & Only Representative (OR) Services
Gateway to EU Compliance: Your Trusted
Only Representative for EU REACH Registration
UK REACH
Closing UK REACH Gaps with
Tailored Solutions and Expert Support
Global Compliance
Stay Informed About The Changing Global Regulatory Landscape To Maintain Ongoing Chemical Compliance
Toxicology and Risk Assessment
Stay Compliant with a Deep Understanding of Toxicology and Risk Assessment Principles
Product Stewardship
Driving Sustainable Product Development For A Safer, Greener Future
Product Safety & Compliance
Understand Inherent Hazards Or Risks Of Products And How To Achieve Compliance
C&L and Poison Centre Notifications
Stay Compliant with the CLP Regulation
Market Access & Regulatory Strategy
Ensure Compliance With Diverse Market Access Requirements
EPR Compliance
“ Profound expertise and deep understanding of REACH regulations.”
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“The complete confidence we have in H2 Compliance’s work”
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“Products have continual market access.”
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“Excellent response time , professionalism, experience “
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“Your services help us to be compliant to EU/UK REACH.”
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Unlock Your Pharma Potential with End-to-End Compliance Support
Industry Insights & Resources
