The field of analytical chemistry plays a crucial role in drug and pharmaceutical product development. As the scientific, technical, and regulatory landscape of the industry evolves, it is important for organizations to stay ahead of the curve. Whether you are a virtual company or a traditional pharmaceutical company, our team of scientific experts can help you navigate the unique challenges of drug and pharmaceutical product development.
From early-stage development to manufacturing support, our experts are equipped to assist you every step of the way. We can help you formulate development strategies that take into account the latest advancements in analytical chemistry, from lead candidate selection to managing Chemistry, Manufacturing, and Controls (CMC) issues such as formulation changes and filing of submissions worldwide in Common Technical Document (CTD/eCTD) format. This includes Pre-INDs, INDs, CTAs, BLA, NDAs, NDSs, MAAs, 510(k)s, PMAs, IMPDs, Pre-Submission Briefing documents, Investigator’s Brochures, Annual Reports, and Integrated Summaries of final regulatory submissions and post-market activities. Our experts are here to help you make the most of your investment in drug and pharmaceutical product development through their deep knowledge of analytical chemistry.