Blog - Compliance Insight

July 23, 2025by t_king

Data Integrity and ALCOA+

July 17, 2025by t_king

The Common CMC Pitfalls

July 11, 2025by t_king

Top 10 FDA CRL Drivers (2020–2024)

Cell_Gene Therapy

July 8, 2025by t_king

Regulatory Insight for the Future of Cell Therapy

FDA findings

June 6, 2025by t_king

Top 5 Hidden Culture Risks That Lead to FDA Findings – And How to Fix Them

June 5, 2025by t_king

FDA 483 Observations FY 2024

June 3, 2025by t_king

Why Classic GMP Training Fails — and What to Do Instead

Medical-Devices-scaled

March 6, 2025by t_king

Key Requirements for Importing Medical Devices

March 3, 2025by t_king

How to Prepare for an FDA Audit and Avoid Common Pitfalls

August 16, 2024by t_king

How AI is Revolutionizing Medical Diagnostics!

Warning Letter

August 14, 2024by t_king

Understanding the Critical Differences

August 12, 2024by t_king

Understanding the Implications of Delays, Denials, and Limitations on FDA Inspections

August 8, 2024by t_king

FDA Mock Audit vs. FDA cGMP Audit

August 6, 2024by t_king

User Fees FY 2025

July 24, 2024by t_king

Preparing for the Future of LDTs

July 22, 2024by t_king

Tests Outside the Phaseout Approach

July 17, 2024by t_king

FDA Guidance on Application User Fees for Combination Products (2024)

July 17, 2024by t_king

Phaseout Approach for LDT Rule Implementation

July 15, 2024by t_king

Impact on Research Use Only (RUO) Manufacturers

July 11, 2024by t_king

Impact on IVD Manufacturers

July 10, 2024by t_king

LDT’s Detailed Impact on CLIA Labs