Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

Validation And Qualification Approach In New Annex 1 Revision
The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.
Development Of An Effective LC-MS/MS Cleaning Validation Method
Gain insight into a robust LC-MS/MS method for quantifying therapeutic peptides that supports contamination control and cleaning validation to ensure product safety and integrity.
Understanding Modern Storage Tank Design And Fabrication
Industries rely on advanced storage tanks and pressure vessels to safely manage liquids, gases, and powders. Discover how custom-engineered solutions can enhance efficiency, safety, and compliance.
Client Story: Efficiency Enabling CSV At Scale
Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology
11/17/2023

Building the right cleanroom involves critical early decisions. Learn about a methodical framework ensuring flexibility, compliance, and operational readiness from initial concept through delivery.
Liquid Phase Peptide Synthesis: Regulatory, Analytical, And QC Perspectives
10/3/2025

Discover how Liquid Phase Peptide Synthesis (LPPS) uses traditional reactors to create more efficient and sustainable peptide manufacturing. Learn about key analytical and quality control considerations.
Boston Scientific: Enterprise Asset Management
8/8/2025

Examine how Boston Scientific uses RAM to centralize asset management to boost compliance, efficiency, and visibility for maintenance, calibration, and validation across facilities.
Simple In-House Mycoplasma Testing Method For Regulatory Expectations And Rapid, Confident, And Actionable Results
5/29/2025

In this webinar, we present an overview of worldwide regulatory guidance for mycoplasma testing, as well as a mycoplasma testing method that has been accepted by regulatory authorities worldwide across various therapeutic modalities.
Nitrosamines - New Requirements To Evaluate Contamination Risks
12/23/2024

Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

Instrument For Accurate Filter Integrity Testing

The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.
Enterprise Maintenance Management

Streamline maintenance with a paperless platform that boosts uptime, ensures GMP compliance, and improves efficiency through automation, mobility, and KPI-driven insights.
Optima™ XPN Ultracentrifuge

1,500 mL max rotor capacity 100,000 max RPM 802,400 x g

Security and tracking Remote monitoring and control eXPert simulation software.
Annex 1-Compliant Real-Time Viable Particle Counter

What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
A Leading Digital Validation Platform For Life Sciences

Discover Kneat Gx, a leading digital validation platform trusted by top Life Sciences companies, reducing validation time and costs while enhancing compliance, scalability, and efficiency.