Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

3 Key Considerations In Gene Therapy Manufacturing
Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.
How Intelligent Automation Transforms CQV Workflows
Discover how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.
EU GMP Annex 1 Compliance: Global Requirements And PIC/S Alignment
The 2023 revision of EU GMP Annex 1 resets the global standard for sterile manufacturing. Learn what’s changed and how PIC/S alignment extends these requirements to many non-EU markets.
How Generative AI Streamlines GxP Compliance In Life Sciences
Generative AI is reaching a critical juncture in the life sciences industry. Learn how it is changing the game for GxP Compliance and enabling organizations to improve operational efficiency.

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time
3/24/2025

As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.
A Practical Packaging Components Checklist For Emerging Biotechs
6/20/2024

A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
Integrating Phase-Appropriate Quality Standards
12/9/2024

Incorporating phase-specific quality standards ensures GMP compliance. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages development timelines.
Validation Of A Sterilization Process: Part 1
9/9/2025

Gain essential insights into sterilization by exploring microbial inactivation kinetics, bacterial spore resistance, and key terminology—critical knowledge for ensuring product safety and compliance.
From Compliance To Process Control: Enabling Preventive Monitoring Through Smart CPV
7/3/2025

Learn to leverage Continued Process Verification (CPV) and analytics for early detection of process drift, enabling preventive monitoring and enhancing overall process robustness.

Proven Vial Containment That Scales From R&D To Commercial

Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
Cleanroom Capabilities And Expertise

Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.
Combat Nitrosamine Challenges With Comprehensive Analytical Solutions

As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.
Microbial Testing Solutions For Pharma QC

Discover how microbial testing services can streamline QC workflows, ensure regulatory compliance, and reduce resource strain with tailored equipment and expert support.
Software To Automate And Digitalize Data Recording Steps In QC Workflows

Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.