Why Abzena?
Our focused approach.
PPQ demonstrates that a manufacturing process is reliable. It’s important for regulatory compliance and commercialization as it shows you can consistently produce products that meet predefined quality criteria. Our experienced scientists, engineers and advisors work with your team to develop tailored protocols and support you in delivering quality, reliable data for your regulatory filings.
Our systematic, science-led approach is built on a deep understanding of your product, process, and analytics, as well as the regulations, guidelines, and expectations of global regulators.
Through the experience of our leadership team there are many hundreds of commercially available products that are helping patients get the medicine they need.
By creating a PPQ strategy we mitigate risk and define your validation campaign, ensuring the success criteria of your program including the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
We understand your product’s process requirements, its development pathway, and its market and patient potential allowing us to develop the right profile for commercial launch.
Our approach to your PPQ is to work directly with your team to ensure we include:
We adapt our approach, shorten the lead times, and develop risk mitigation strategies to ensure your overall success.