Navigating the ever-evolving scientific, technical, and regulatory environment in the pharmaceutical industry is crucial for organizations to stay competitive. If you’re an investor, a traditional or virtual pharmaceutical company looking to delve into the life sciences sector, or planning to sponsor the development and market launch of a drug product, our team of scientific professionals is here to guide you through the unique intricacies of drug and pharmaceutical product creation.
Our specialists are on hand to support you right from the initial stages of development through to analytical testing and will assist in obtaining necessary product licensing and manufacturing for commercialization.
We’ll collaborate with you to create development strategies that leverage cutting-edge advancements in product development studies. Our services encompass the entire drug development cycle from lead candidate selection to managing Chemistry, Manufacturing, and Controls (CMC) challenges like formulation modifications and regulatory submission filing in Common Technical Document (CTD/eCTD) format. This comprises 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, as well as post-market activities.
Our experts’ profound understanding of analytical chemistry will ensure you maximize your investment in drug and pharmaceutical product development. Let us be your guiding hand in this dynamic industry landscape.