At Janus, we incorporate rigorous quality control protocols, especially during scale-up. Our approach includes process validation, impurity profiling, and in-line monitoring to ensure that API intermediates maintain their chemical integrity and meet all specifications through each stage of scaling. We also conduct stability testing to verify consistency across batches.

Regulatory requirements vary significantly between regions, particularly regarding acceptable impurity limits and documentation. Our regulatory affairs team works to ensure that all API impurities adhere to ICH guidelines and specific regional mandates, including those from the FDA, EMA, and other regulatory bodies. This includes documentation preparation, impurity characterization, and validation reports as needed for international markets.

Yes, we offer custom synthesis services that are well-suited to early-phase development. Our R&D capabilities include route scouting, process optimization, and scalable manufacturing, enabling us to support lead optimization and pre-clinical synthesis needs. We work closely with clients to optimize reactions for efficiency, yield, and purity while planning for potential scale-up.

Our lab employs advanced analytical techniques such as HPLC, GC-MS, NMR, and LC-MS to identify and quantify impurities accurately. We also use specialized degradation studies and forced degradation profiling to predict and control impurity formation, thus ensuring product safety and compliance throughout the product lifecycle.

For high-purity fine chemicals, process validation is critical to ensuring consistent quality. Our validation protocols include defining critical quality attributes (CQAs) and critical process parameters (CPPs), along with conducting thorough risk assessments. We monitor and control these parameters through multi-stage validation studies to achieve reproducible results across production batches.

Yes, our CRO services are highly customizable to meet distinct regulatory requirements across different jurisdictions. We assist clients with full-spectrum regulatory documentation, bioanalytical method development, stability studies, and scale-up processes. We ensure that our practices are aligned with international standards, supporting clients with regulatory submissions for markets worldwide.

Janus offers a highly flexible production capacity, tailored to meet both small and large-scale production demands. Our facilities are designed for adaptability, allowing us to quickly transition between projects of varying scale. We also offer seamless project management support, ensuring efficient handling of volume fluctuations and complex project timelines.

We prioritize data integrity and confidentiality by implementing secure data management practices and a robust IT infrastructure. All project data is stored securely, with access controls, encrypted data transfers, and strict adherence to confidentiality agreements to ensure that client information is protected at all times.

Our regulatory affairs team collaborates with clients from the outset to address regulatory challenges, particularly for complex synthetic compounds. We provide impurity profiling, detailed analytical characterization, and comprehensive documentation, including Drug Master File (DMF) preparation and submission, to ensure regulatory clarity and product compliance across global markets.