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Expert Guidance for Compliance Across Regulated Industries.

Industries We Serve

Medical Device

  • ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes

  • 21 CFR Part 820: Quality System Regulation - Medical Devices

  • ISO 14971: Medical devices - Application of risk management to medical devices

  • TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.

Pharmaceuticals

  • 21 CFR Part 210 & 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

  •  Pharmaceutical Ingredients

  • ISO 9001: Quality management systems - Requirements

  • ICH Q10: Pharmaceutical Quality System

  • TGA GMP: Human blood and blood components, human tissues and human cellular therapy products

Contract Manufacturing

  • ISO 9001: Quality management systems - Requirements

  • 21 CFR Part 820: Quality System Regulation - Medical Devices

  • ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes

  • TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.

Industries - Roystonea Compliance Tissue Banks Quality and Regulatory Compliance Support

Tissue Banks

  • 21 CFR Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products (FDA)

  • AATB Standards: American Association of Tissue Banks Standards for Tissue Banking

  • TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.

Laboratory Testing

  • ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories

  • 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies

  • TGA GMP: Human blood and blood components, human tissues and human cellular therapy products

Cold Chain Industry

  • ISO 9001: Quality management systems – Requirements

  • ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories

  • TGA GMP: Human blood and blood components, human tissues and human cellular therapy products.

Our expertise ensures that your operations are compliant, efficient, and meet the highest standards of quality and safety.

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