Our experienced scientists, engineers and advisors work with your team to develop tailored protocols and support you in delivering data for your regulatory filings.
Streamlining your project, 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.
Many hundreds of commercially available products are helping patients thanks to the experience of our leadership team.
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 are committed to achieving quality excellence. We are transparent in our communications and work collaboratively to progress your programs.
Our team collaborates with you and uses deep scientific and technical know-how to find the best solutions using the right technologies to deliver your program with a constant commitment to quality.
We adapt our approach, shorten the lead times, and develop risk mitigation strategies to ensure your overall success.
