#processchemistry

We strongly believe in the importance of effective Quality by Design (QbD) during process development. We involve a cross-functional team of analysts, process engineers, quality assurance, sourcing and manufacturing experts that help to consider right input variables during designing and developing the process. This enables the team to achieve one of the elements of ICH Q10 quality system: continual improvement within the boundaries of design space with minimum regulatory consent to the customer. By deploying a QbD approach, we enable clients to build the required quality into the product during the design and development phase by understanding the effects of material attributes and process parameters on Critical Quality Attributes (CQAs). To know more click on the link 👉 https://lnkd.in/gknsdXJV

Eurofins Advinus strongly believes in the importance of effective Quality by Design (QbD) during process development. We involve a cross-functional team of analysts, process engineers, quality assurance, sourcing and manufacturing experts that help to consider right input variables during designing and developing the process. This enables the team to achieve one of the elements of ICH Q10 quality system: continual improvement within the boundaries of design space with minimum regulatory consent to the customer. By deploying a QbD approach, we enable clients to build the required quality into the product during the design and development phase by understanding the effects of material attributes and process parameters on Critical Quality Attributes (CQAs). To know more click on the link 👉 https://lnkd.in/gknsdXJV

The drug development path is long and has many challenges. Eurofins Advinus works to get the right balance of speed, cost, quality to ensure your success. Our team focuses on best practices to enable rapid process development and scale-up of your drug substances. Our capabilities include route scouting, fit-for-purpose process development, process safety evaluation, analytical method development and validation, stability studies and scale-up of drug substances for toxicity assessment and clinical studies. The scientific team is well versed with spike/purge studies, impurity identification, in silico analysis to assess Potential Genotoxic Impurities (PGIs) in drug substances. Our facilities are well equipped and have QP-audited cGMP plant and clean-rooms for manufacturing of drug substances for clinical and commercial use. To learn more about our services click on the link - https://lnkd.in/d5aTHP_u

The team at Eurofins Advinus is able to help you overcome challenges with your CMC and CDMO requirements. We have expertise in complex multi-step synthesis that enables successful rapid progress of your R&D programs. We have QP-audited cGMP plant and clean-rooms for manufacturing of drug substances for clinical and commercial use. Our services include – Process Research and Development Analytical Development Process Safety Manufacturing

Eurofins Advinus offers comprehensive Chemistry, Manufacturing & Controls (CMC) services for drug substance development and manufacturing. Our team has expertise to develop robust processes that are safe and reliable. Email us at [email protected] for all your non-GMP and cGMP requirements

Eurofins Advinus has expertise in process chemistry along with analytical solutions to assist you accelerate and advance your drug development programs. Connect with our team at [email protected]