Boyan Litchev MD

We Elevate Your Biotechnology and Pharmaceutical Endeavors to Achieve Success Faster. We specialize in assisting biotech and pharmaceutical companies by optimizing their clinical and regulatory strategies, productivity, and operations. Our efficient and cost-saving solutions, including Artificial Intelligence (AI)-powered tools, add value from proof of concept through all phases of clinical trials, submission, approval, launch, and commercialization of innovative therapeutic modalities. Our unique expertise addresses challenging treatment platforms that others may avoid or where progress has stalled. We transform these challenges into success stories. We offer comprehensive guidance in clinical trial design, medical strategy and monitoring, regulatory and safety considerations, and relationship building. Our services span from Research, Pre-clinical, and Translational stages through to clinical trials, IND, NDA, BLA submissions, approvals, and product launches. Our approach is tailored to create efficiencies in clinical development, operations, regulatory affairs, medical affairs, and safety strategies, customized to each company's objectives, teams, clinical programs, and innovative pipelines. We have extensive knowledge and experience working with diverse environments, from small private ventures to pre-IPO and public biotechnology and pharmaceutical companies, including CROs. We have a proven track record of accelerating clinical development processes, achieving cost efficiencies, and leading high-performing teams. We are committed to driving success for your team or company. For assistance, please contact me by email or message here.