Our pre-clinical development team uses its extensive experience in working with novel targets and therapeutics to help you reach your IND submission milestone and beyond.
InClinica works with you to truly understand the development needs of your project. We evaluate data gaps, help you probe the molecular target of interest, and look for off-target effects, potentially leading to further optimization of the therapeutic agent you’re developing. We know the importance of validation studies – from the pharmacological to the analytical — and ensure that any vendor laboratories follow industry-standard GLP guidances.
Our team has deep knowledge of Pharmaceutical Quality/CMC (chemistry, manufacturing and controls) issues and recognizes the critical importance of comprehensive drug substance, drug product, and analytical data packages to the scale up and formulation of an investigational product. We will also help you work effectively with world class patent firms to both secure your patent position and understand the competitive landscape.