Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

Streamline Drug Development With A Lab Informatics Platform
Learn how a tiered approach to ADME-Tox studies can help researchers navigate early-stage preclinical research and mitigate the risk of costly failures in drug development.
Navigating Your Holistic Approach To CCI For Biologic Drug Products
Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.
From Readiness To Results: Unlocking Capacity For Expanding Product Demand
Learn the six pillars that bridge operational readiness and operational excellence. Discover a proven framework to build a resilient, high-performing manufacturing operation and unlock necessary capacity.
Normalized Data In Microbial Continuous Monitoring
Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

GMP Twins: Making Digital Twins Real In GxP Manufacturing
11/12/2025

True digital twins are redefining pharmaceutical manufacturing. Learn key distinctions, GMP-aligned frameworks, and real-world applications in predictive quality, CPV, and intelligent optimization.
Performance Dashboards Development
7/22/2025

Learn about a biotech company's successful implementation of a two-level KPI dashboard system. This enhanced performance monitoring, aligned departmental goals, and strengthened team communication.
Why Established Pharma Sites Need A Digital Cleaning Validation Strategy
7/23/2025

Pharmaceutical facilities face mounting pressure to modernize. Uncover how digital tools are transforming cleaning validation to boost compliance and audit readiness without disruption.
Navigating GxP Compliance Challenges
10/30/2024

Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.
Leveraging A Modern HPLC System For Peptide Drug Substances Analysis
8/22/2024

This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

A QMS Software That Enhances Operational Excellence

Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.
Regulatory Services Offering

Navigating the path toward regulatory approval is a complex process. Learn how partnering with Societal™ CDMO and leveraging regulatory expertise can empower your organization to achieve its goals.
Enterprise Asset Management Platform

Discover an enterprise asset management system for life sciences that combines maintenance, calibration, and compliance tools to boost productivity, reliability, and GMP readiness.
USP 661.1 Vs 661.2: Key Differences And Compliance

USP 661.1 and 661.2 introduce rigorous, risk-based standards for pharmaceutical plastic packaging, emphasizing material characterization, system suitability, and extractables/leachables testing to ensure safety and compliance.
Contamination Control Products For Annex 1 Compliant Facilities

Explore the details of a contamination control strategy, tips for managing disinfectant residues, general guidelines for removing disinfectant residues, and a wide range of products for cleaning and disinfection.