At RGBSI, we deliver product and sustainability services which enable clients to meet regulatory compliance requirements. This includes handling submissions, data coordination, and report generation necessary in the automotive and healthcare and pharma industries.
Healthcare & Pharma
Product Compliance
We can handle all the work around supplier submissions, including requests and reviews of supplier submissions and supplier training. In addition, we generate letters of compliance/non-compliance on our clients’ behalf for but not limited to IMDS, REACH, RoHS, Prop 65, and Conflict Minerals. Document creation funnels through RGBSI and is reported on our clients’ behalf to their end customers (OEMs).
Sustainability Compliance
We perform all services around sustainability compliance. This includes requesting and reviewing supplier submissions from suppliers, as well as conducting supplier training. On behalf of our clients, we create final sustainability reports by coordinating data from different departments, completing all questionnaires, and uploading the final questionnaire into regulatory sites for the following:
- Carbon Disclosure Program (CDP) relative to climate, water, and forest.
- We also provide services for campaigns including:
- Anti-Bribery and Anti-Corruption
- Child Labor
- Human Trafficking and Slavery
- Code of Conduct
IMDS
Compliance data collection, entry, and cleansing initiatives for International Material Data System (IMDS)
REACH
Registration Evaluation Authorization & Restriction of Chemical Substances
RoHS
Restriction of Hazardous Substances
Conflict Minerals
Responsible minerals initiative (RMI), formerly Conflict Free Sourcing Initiative (CFSI)
Waste Management
(European Regulations)
WEEE
Waste Electrical and Electronic Equipment
ELV
End-of-Life Vehicles
Battery Directives
Prop 65
California Proposition 65
Montreal Protocol
CDP
Carbon Disclosure Program
ITAR
International Traffic in Arms Regulations (ITAR) defense support
CPA
Covered Product Authorization
HCQIA
Healthcare Quality Improvement Act of 1986
SOX
Sarbanes-Oxley Legislation
HITECH
Health Information Technology for Economic and Clinical Health Act
CDSCO
Central Drugs Standard Control Organization
ACA
Affordable Care Act
MDR
Medical Device Regulation