Legal and Regulatory | Contract Laboratory

Legal and Regulatory Articles

Cleaning Validation: Regulatory Expectations and Methodologies

By Craig B. | Jul 17, 2025

Ensure product safety and regulatory compliance. Discover essential cleaning validation strategies and methodologies for your laboratory operations.

Pharmaceutical professional in cleanroom attire working at a sterile containment unit with biohazard signage, preparing or inspecting equipment for contamination control.

Scientist using a pipette to transfer liquid into labeled microcentrifuge tubes at a laboratory workstation.

CAPA Systems in GMP Environments: Essential Best Practices

Jul 10, 2025

Shipping containers with imported products are stacked at a port or freight facility.

Tackling FDA Import Detentions with Third-Party Lab Testing

Jun 13, 2025

FDA Approves ELISA Companion Diagnostic

Jun 5, 2025

ASK THE LAB EXPERT: Promoting User-First Lab Automation with AI-Powered Innovations

May 8, 2025

E-Commerce Compliance for Third Party Sellers

Jun 24, 2024

A comprehensive webinar on navigating regulatory and compliance requirements for importers, manufacturers, and third-party online sellers by Norman Aronowitz

ASTM Releases New Standards for Various Sectors

Jun 19, 2024

New ASTM Standards prioritize safety, efficacy, and sustainability

Hemp Flower Proficiency Testing Program Gains ISO 17043 Accreditation

Jun 19, 2024

"In states where cannabis is legal, participation in a proficiency testing program is often required by regulators

FDA Takes Action to Ensure the Safety and Effectiveness of Laboratory Developed Tests

May 30, 2024

"The final rule announced today ensures that health care decisions are based on reliable test results." - Robert M. Califf, M.D.

Understanding Sanitary Standard (SSI)

May 10, 2024

The Sanitary Standard (SSI) is a globally recognized organization committed to setting and upholding rigorous sanitary and hygiene standards across various industries.

Navigating Compliance: Saudi Arabia’s SASO-SABER System

May 10, 2024

Ensuring ongoing compliance with SASO regulations is essential for maintaining certification and market access.

A Comprehensive Guide to Conducting Contract Laboratory Vendor Audits

May 10, 2024

By following a systematic approach and adhering to best practices, organizations can effectively evaluate the capabilities, processes, and performance of contract laboratories, mitigate risks, and foster trust and confidence.