Chemistry, Manufacturing and Controls (CMC) is a critical part of the new therapy development pathway. As part of the FDA regulatory process for approval, it requires all information relating to a new product is collated – ranging from specifications, manufacturing process control parameters, stability parameters and analytical test variance data etc. Aggregating and ensuring the regulatory integrity of this information from the many different systems that hold it is a time consuming and complex task. Zifo has regulatory expertise and technology partnerships that can reduce the burden of CMC and help speed up new product approval.
Our Capabilities
Our expertise spans the whole spectrum of scientific process applications, and we’re able
to draw on a huge marketplace of partnerships with science technology providers, so
whatever is needed to fix your current set-up. we’ll determine the best way forward.
Our People
Our people are our business and we invest and support their development and curiosity. We actively promote science in our daily work and over 90% of people in Zifo have a scientific background – meaning we speak & understand the language of science
Glocal
We have a GLOCAL (global & local) presence – meaning we engage with you in your language and time zone but leverage a global delivery support model to remain cost-effective, scalable and very reactive
Focus
We focus on science and scientific process applications and informatics. This means we can provide expertise and domain knowledge without compromising quality, technical and service delivery excellence
Partnerships
Our huge marketplace of partnerships with science technology and informatics platform providers means you can rely on Zifo to be agnostic and advise on strategy, plan & deliver projects, and validate and maintain your scientific informatics environments
