We have been in your shoes, worked in small company teams. We have a track record of developing cutting edge therapies with limited resources and tight, ever changing timelines. Our team has extensive biotech and pharma background in Sponsor roles for multiple technologies. We have directly experienced the benefits and the pain of partnering with CROs unaccustomed to Advanced Therapeutics.
We are strategists and tacticians. We partner to deliver a holistic, customized approach, tailored to the needs of your unique product. As nimble and flexible extensions of your team, we provide efficient development options from early feasibility to high value exit strategies or through pivotal trials and commercialization. Our offerings define and sharpen clinical development plans. This includes phase appropriate manufacturing control, product characterization, regulatory, reimbursement/market access, safety signal detection, and clinical study design/execution.
Our expertise includes unique antimicrobial/ microbiome, cell and gene, and combination products. It builds upon the successful BBA history of developing complex device platforms.