For over two decades, we have been a trusted partner to the life science industry in supporting several important drug development programs. We are offering a broad range of strategic services covering entire product life cycle. We focus on partnership with our clients and ensuring the highest scientific quality and compliance in everything we do. We will support you across the cumbersome and challenging path of drug development, especially if you are a smaller emerging biotech company. Our experts know the structure of the big and colorful drug development puzzle, can help you putting together the complete picture or find out and solve the key missing pieces that prevented your program progress at the desired speed and within the planned budget.
Our consultancy team is composed of seasoned professionals coming from various fields. We approach every development program very seriously lining up a multidisciplinary team comprising Medical Experts, Translational Scientists, Regulatory Specialists covering all three aspects CMC, Toxicology, and Clinical, Clinical Pharmacologists, Biostatistician, Biomarker Expert, Clinical Trial Specialist, QA Expert. We create drug development plans in compliance with the most rigorous regulations to deliver the best results for our clients. Feel free to approach us irrespective if you need full, E2E, or just services as per need, or services by specialty areas in drug development.
Our multidisciplinary team is available to assist you from the beginning of the product life cycle i.e., from discovery & formulation to the CMC development and the nonclinical toxicology. We provide unparalleled expertise to emerging pharmaceutical and biotech innovators seeking product approvals in major global markets.
Our primary focus is a partnership with our clients and the delivery of the highest scientific quality, without ever losing sight of the big picture and budgetary conditions.
Our dedicated preclinical team is available for consulting, strategic planning, due diligence, regulatory support, technical writing, document compilation, gap analysis in all aspects of preclinical development.
The clinical phase is the most complex, expensive, and lengthiest period of a medicinal product’s development. In addition, this phase bears the highest risks for the product’s survival. Often, study results are inconclusive, making it tough to decide how to progress forward or stop the entire development program. Sometimes companies advance their programs into more costly next steps based on inconclusive data and consequently incur significant financial losses.
About 70% of the products in phase 1 will move to the next stage, and about 33% will move on to the phase 3 portion (often an extremely costly and protracted phase). Finally, 25 to 30% of these candidate medicinal products will be subject to regulatory submission. Several drug candidates will finally fell at this stage.
We cannot guarantee that your product will succeed. However, we can provide competent advice to mitigate the risks of the inconclusiveness of your study results, contributing with this to investment optimization and timeline improvements. We’ll help you focus right from the beginning on those factors that are critical to ensuring a conclusive outcome of your studies.