ADRES’s mission at this stage is to protect companies from delays while staying within budget. We help our clients prioritize and focus on the steps needed to creatively turn their vision into reality.
ADRES guides you through the preclinical stage, preparing you for phase 1 clinical trials. We help design preclinical studies to ensure you are set up with relevant safety data, and consider animal welfare, including interacting with global regulatory authorities.
As the product moves closer to reality, it’s time to connect all the dots. We help keep everything moving forward, from preclinical studies, non-GMP and GMP materials, working with analytical methods laboratories and CROs, and interacting with global regulatory authorities.
Towards completion of the clinical stage, it’s time to provide the regulatory authorities with all the data and knowledge accumulated in support of the product approval. ADRES helps you prepare documentation demonstrating the efficacy and safety of the product. We manage interactions with global regulatory agencies, balancing their expectations with your needs and strategy.
ADRES can work with your existing team, providing agility and expertise as you navigate legal requirements to bring your product to market.