CARBOGEN AMCIS has a track record, extending over 25 years, helping our customers transition their molecules from process development through validation and ultimately into commercial status. A range of services backed up with fully integrated support functions has been developed to facilitate and smooth the path to the commercialization of a compound.
I enjoy the responsibility to consult customers and colleagues on regulatory affairs as well as the challenging projects we encounter that are in different clinical phases or with commercial products – it's a very dynamic industry and environment.
Dietmar - Head of Regulatory Affairs, Bubendorf
For Registration Campaign and Process Validation, we have a flexible late-phase approach, depending on customer requirements; with an up-front strategy, created and tailored along with our customers, based on sensitivity to risk & overall cost. Our methodology and process is fully compliant with ICH Q7, 8, 9, 10 & 11 and follows a Quality by Design programme, including PAR (Proven Acceptable Ranges) studies.
We systematically screen the important process parameters through optimization and process characterization, by statistical DoE (design of experiments) and each project is subject to rigorous product quality risk assessments. Lifecycles are validated according to FDA guidelines.
Our teams generate all supporting data for filing, including synthesis & characterization of analytical standards, forced degradation studies, stability data & others as required for each project, including late phase Documentation (PPA, QRIA, PAR, Process Summary, PV, PQR- Reports).
Many of our customers take advantage of our experience in planning appropriate strategies for registration and process validation. Once the compound is supplied for later clinical phase trials our dedicated team transition into the project. We have understood that the disciplines required at each stage of the product life-cycle are usually varying and that this requires different skill sets and processes. To this end we have an established team, made up of highly experienced and educated technical staff with a background in commercial project guidance and management
CARBOGEN AMCIS inherently understands that there is a need to plan for the future and not just for today. Our highly-experienced Project Managers are tasked to work with you; from successful validation to the final phases of your product. This ensures proactive input at the appropriate time in order to ensure that the best value can be derived from the product for our clients. Within the Dishman CARBOGEN AMCIS Group, we have facilities and capabilities available to ensure that a wide range of potential strategies can be pursued to mitigate risk and maximize value.
of experience in commercialisation
currently supplied into the major markets
per year, including new HiPo products