Quality Control

INSIGHTS ON QUALITY CONTROL

Development To Large-Scale cGMP Production
For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.
The Importance Of Having A Strong Reject Characterization Program
Discover how linking inspection results to systematic defect analysis strengthens data integrity, accelerates root cause resolution, and satisfies regulatory process knowledge requirements.
Enhance Peptide Innovation With A High-Quality Supply Of Building Blocks
To leverage the benefits of peptide therapeutics, identify an experienced chemical material manufacturer that can produce unique peptide building blocks with quality, efficiency, and continuous compliance.
Lessons From FDA 483s And Warning Letters: Cleanroom Compliance
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

ICH Q9 Revision 1: Enhancing Quality Risk Management
8/12/2024

ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
Inside The Cleanroom: Building A Culture Of Clean Beyond The CCS Blueprint
2/12/2026

Achieving sterile excellence requires more than just rigid protocols. Learn how to foster a proactive mindset across your entire organization to ensure long-term facility integrity.
Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications
6/19/2025

Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.
Environmental Monitoring In Advanced Therapeutic Medicinal Products Facilities
3/5/2026

Discover how to adapt your environmental monitoring framework to meet the distinct risk-management and regulatory needs of ATMP facility production.
Build A Culture Of Clean To Elevate Your Cleanroom
2/12/2026

Keeping your cleanroom spotless is vital for product quality and patient safety. Consider these important factors for how to build a culture of clean and how your cleanroom will benefit.

Dynamic Pass Boxes And Dynamic Floor Laminar Hatches

Protect your clean suites with active material airlocks. These systems utilize vertical laminar airflow to flush contaminants, ensuring seamless, compliant transfers between cleanliness zones.
Quality, Compliance, And Regulatory Services For Life Sciences

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
Minimizing Uncertainty Throughout The Development Lifecycle

Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.
Quality Drive + People Powered

An integrated development and manufacturing approach that cuts handoffs, manages risk, and accelerates timelines by uniting formulation, analytics, production, and packaging.
Europe's Leading Pharmaceutical CDMO

Our solid forms plant exports 75% of its output, supplying products to 45 markets in 25 different languages.