What is Region-Specific SDS Customization?

Our service tailors SDS/MSDS to meet regulatory, linguistic, and formatting requirements for regions like the EU, US, Canada, India, and more, ensuring global compliance with accurate translations and hazard labeling.

Why is it Critical?

Customized SDS ensures regulatory compliance, workplace safety, and effective hazard communication across diverse markets, supporting global distribution and regulatory approvals.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led SDS customization, providing precise, compliant, and multilingual documentation to streamline regulatory submissions and ensure market readiness.

Our Expert Customization Approach

At Indivirtus Healthcare Services, our Region-Specific SDS Customization services are led by certified regulatory experts and linguists specializing in global chemical safety. We adapt SDS to comply with EU REACH Annex II, OSHA HCS, WHMIS, IS 17803:2022, and other regional standards, incorporating accurate multilingual translations and region-specific hazard labeling.

Our tailored approach ensures compliant and market-ready documentation, addressing regulatory nuances and linguistic requirements to support safe handling, global distribution, and regulatory acceptance of pharmaceutical products.

Region-Specific SDS Deliverables

Country-Specific SDS Formatting and Section Adaptation: Tailored SDS for target market regulations.

Compliance with EU Annex II, OSHA HCS, WHMIS, IS 17803:2022: Region-specific regulatory alignment.

Professional Translations for Multilingual SDS: Accurate translations for EU, APAC, GCC, and other regions.

Hazard Labeling Aligned with Local Rules: Precise hazard and precautionary statements for compliance.

Bilingual Versions for Dual-Market Submissions: SDS in formats like English + French for multi-market use.

Regulatory Compliance & Global Standards

Our Region-Specific SDS Customization services align with stringent global and regional standards, ensuring your documentation is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance safety and regulatory confidence.

  • EU REACH Regulation – Annex II: European requirements for SDS formatting and content.
  • OSHA Hazard Communication Standard (29 CFR 1910.1200): U.S. regulations for workplace safety documentation.
  • WHMIS 2015 (Canada): Canadian standards for hazardous materials information.
  • Indian Standard IS 17803:2022: Indian regulations for chemical safety documentation.
  • UN GHS (Purple Book): Global standard for chemical hazard classification and labeling.

Applications & Use Cases

Our Region-Specific SDS Customization services are essential for pharmaceutical manufacturers requiring compliant hazard communication for global markets. Ideal for regulatory submissions, workplace safety, and multi-regional distribution, our solutions support safe handling and compliance. Key use cases include preparing SDS for APIs and drug products, ensuring compliance for EU/US/Canada/India markets, and supporting multilingual submissions for global supply chains.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led SDS customization solutions backed by certified regulatory experts and linguists with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we empower your organization with compliant, accurate, and multilingual Safety Data Sheets, driving regulatory success and global market readiness.

Frequently Asked Questions

Frequently Asked Questions

What is the need for region-specific SDS customization?

Different countries have specific formatting, language, and hazard communication rules. Customizing SDS ensures regulatory compliance and avoids product rejections.

Can you provide SDSs in regional languages?

Yes. We offer SDS translations in major regional languages including French, Spanish, Chinese, Arabic, and Indian vernaculars to meet local market requirements.

How is Indian SDS formatting under IS 17803:2022 different?

IS 17803:2022 mandates country-specific elements like emergency contact details, local classification alignment, and language preferences, which we incorporate during customization.

Is WHMIS compliance needed for Canada?

Yes. WHMIS 2015 requires SDSs to follow Canadian GHS implementation with specific content, symbols, and bilingual (English/French) presentation for hazardous substances.

What data do I need to share for region-specific SDS preparation?

You need to share the base SDS, product composition, regulatory target countries, and any existing compliance data or translations you may have.

What do Region-Specific SDS Customization services include?

Our services include country-specific SDS formatting, compliance with EU Annex II, OSHA HCS, WHMIS, IS 17803:2022, professional translations, hazard labeling, and bilingual versions for dual-market submissions.

Who benefits from Region-Specific SDS Customization services?

Pharmaceutical manufacturers distributing products in the EU, US, Canada, India, or other regions, requiring compliant and multilingual SDS, benefit from our tailored customization solutions.

How do these services ensure regulatory compliance?

Our services align with EU REACH Annex II, OSHA HCS (29 CFR 1910.1200), WHMIS 2015, IS 17803:2022, and UN GHS, ensuring compliance with global and regional regulatory standards.

What deliverables are provided with the service?

Clients receive country-specific SDS, compliance with EU/US/Canada/India standards, multilingual translations, hazard labeling, and bilingual versions for dual-market submissions.

Can the SDS customization services be tailored for our needs?

Yes, our services are customized to your product’s properties, target markets, and regulatory/linguistic requirements, ensuring accurate and compliant SDS documentation.

How do the services support multilingual SDS for global markets?

We provide professional translations meeting official terminology standards for regions like EU, APAC, and GCC, ensuring compliant and accurate SDS for global distribution.