Our Expertise

Our SDS/MSDS Services

Indivirtus provides expert Material Safety Data Sheet (MSDS) and Safety Data Sheet (SDS) preparation services to ensure compliance with global chemical safety regulations. We deliver GHS-compliant, 16-section SDS tailored to regional standards like OSHA, EU REACH, and India's IS 17803:2022, supporting pharmaceutical manufacturers, biotech firms, chemical producers, and CROs. These services are critical for ensuring worker safety, environmental protection, and regulatory compliance across clinical, manufacturing, and distribution processes.

MSDS SDS preparation service for pharmaceuticals

Our SDS Expertise

Our SDS Preparation Process

Data Collection

We gather toxicological, ecotoxicological, and chemical data from ECHA, TOXNET, and other databases.

1

Hazard Assessment

We classify hazards per GHS categories and prepare compliant labels with pictograms and statements.

2

SDS Authoring

Our toxicologists draft 16-section SDS, ensuring compliance with regional standards like OSHA and REACH.

3

Review & Customization

We review and customize SDS for specific regions, including translations and regulatory alignment.

4

Submission & Support

We submit SDS to regulatory bodies and integrate them into DMFs, CTDs, and other dossiers.

5

Compliance & Standards

Regulatory Bodies

  • FDA (U.S. Food and Drug Administration)
  • EMA (European Medicines Agency)
  • CDSCO (Central Drugs Standard Control Organization)
  • ECHA (European Chemicals Agency)
  • OSHA, WHMIS, BIS

Guidelines & Certifications

  • UN GHS (Latest Version)
  • EU REACH Annex II
  • OSHA HCS 2012
  • WHMIS, IS 17803:2022
  • JIS Z 7253, GB/T 16483

Applications & Industries

  • Pharmaceutical Manufacturing
  • Biotechnology
  • Chemical Production
  • Contract Research Organizations
  • API & Formulation Development

Why Choose Our SDS Services?

Our CRO delivers expert SDS/MSDS preparation services, ensuring compliance with global GHS standards and regional regulations like OSHA, REACH, and IS 17803:2022. With toxicologist-led authoring, multilingual customization, and regulatory submission support, we help you ensure worker safety and streamline compliance. Choose us for accurate, reliable SDS solutions that support your global operations.

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Frequently Asked Questions

Frequently Asked Questions

What is an MSDS or SDS? +

An MSDS (Material Safety Data Sheet) or SDS (Safety Data Sheet) is a detailed document that provides information about the properties, hazards, safe handling, and emergency measures related to chemicals and pharmaceutical substances.

Why is SDS preparation important for pharmaceuticals? +

SDS is required for regulatory compliance and ensures the safe use, handling, transport, and disposal of pharmaceutical substances. It also helps in hazard communication and risk mitigation for workers and downstream users.

Is SDS preparation mandatory? +

Yes, SDS preparation is a legal requirement under various global regulations including GHS, OSHA, and REACH for any hazardous chemical or substance being manufactured, imported, or exported.

What information is required from the client? +

We typically require detailed chemical composition, purity, toxicological and physical properties, usage guidelines, and any known hazards to generate accurate and compliant SDS/MSDS.

Can you help with SDS translation for global markets? +

Yes, we offer multilingual SDS preparation to help pharmaceutical companies comply with regional regulations in Europe, Asia, and Latin America.

Do you support SDS creation for custom formulations? +

Absolutely. We provide tailored SDS creation services for proprietary blends and formulations based on available data and safety assessments.

How often should SDS be updated? +

SDS should be reviewed regularly and updated whenever there is new hazard information or a regulatory change. We recommend reviewing SDS at least every 3 years.

What is included in your SDS/MSDS preparation services? +

Our SDS/MSDS preparation includes a 16-section format compliant with the latest GHS version, covering identification, hazards, composition, safety measures, and regulatory information tailored to global standards.

Which regions do your SDS services cover? +

We customize SDS for regions including the USA (OSHA), EU (REACH/CLP), Canada (WHMIS), India (IS 17803:2022), China (GB/T 16483), Japan (JIS Z 7253), and more, with local language translations.

How do you ensure GHS-compliant hazard classification? +

We assess chemical and toxicological hazards based on GHS categories (health, environmental, physical) and prepare labels with pictograms, signal words, H-statements, and P-statements.

What data sources are used for toxicological assessments? +

We compile data from ECHA, TOXNET, NIOSH, HSDB, GESTIS, and REACH dossiers for toxicological and ecotoxicological information, including LD50, LC50, and biodegradability.

How do you handle updates to existing MSDS documents? +

We convert legacy MSDS to GHS-compliant SDS, perform annual/periodic reviews, update based on new toxicology or regulations, and manage version control with REACH and UFI integration.

Who benefits from your SDS preparation services? +

Pharmaceutical manufacturers, biotech firms, chemical producers, and CROs benefit by ensuring regulatory compliance, worker safety, and proper chemical handling across global markets.

What is the process for regulatory submission of SDS? +

We submit SDS to National Poison Centers (EU Article 45), Indian BIS/CIB, and ECHA under REACH, and align them with DMFs, CTD/ACTD dossiers, and other regulatory documents.

How do you ensure the accuracy of SDS documents? +

Our SDS are prepared and reviewed by trained toxicologists and chemical safety experts, ensuring accuracy, compliance, and regulatory endorsement.

Can you provide multilingual SDS for global compliance? +

Yes, we offer local language translations (e.g., French, German, Spanish, Chinese) to meet multilingual compliance requirements for global markets.

How do you support labeling for chemical products? +

We prepare GHS-compatible labels with pictograms, signal words, H- and P-statements, and support serialization and barcoding for primary and secondary containers.