To support your go–no go decisions with insightful analysis and data about your drug’s ADME properties, a wide range of drug metabolism and pharmacokinetics (DMPK) studies can be run by our team. These studies are completed by our experts in bioanalysis, who check accurate dosage levels and measure drug and metabolite concentration levels in biological matrices.
In parallel, the chemical properties of the drug candidate, such as solubility or stability, also influence its in vivo performances. An efficient chemical development route design, along with formulation development, are also key to ensuring the efficacy of a drug candidate.
To maintain the quality of your drug from lab to shelf, our Analytical Development and QC team has extensive experience in designing reliable and robust analytical test methods. While moving from bench to bedside, our clinical trial supply experts can support the manufacturing of your medicinal products for use in Phase I–IV clinical studies and compassionate use/expanded access programs. These steps are diligently run by our team to minimize risks to humans during clinical development.
To ensure the success of your clinical development program, NUVISAN offers a comprehensive range of services, including regulatory affairs and submissions, clinical data management and statistics, medical monitoring and safety reporting, patient recruitment and retention strategies, quality assurance and auditing, project management and outsourcing solutions, and post-approval support and commercialization planning, all in addition to study design, protocol development, and clinical trial management.