Helping you solve your CMC challenges!
We're here to help you transform your brilliant discoveries into commercial products. Our strategic focus on technical and regulatory CMC topics can help you streamline your projects from concept to implementation. Expect impartial, scientifically rigorous and pragmatic advice to make the most of every opportunity.
We provide strategic guidance and advice to early stage companies in cell and gene therapy, oligonucleotides, combination products and novel biotechnology modalities. We specialize in CMC topics including process development, analytical and formulation projects, selection of manufacturing options, due diligence and regulatory strategy. Whether you're looking for a one-time consultation or on-going support, we'll help you tackle your biggest technical challenges. The patients are waiting for your breakthrough solutions; our mission is to enable rapid implementation of your novel therapeutics.
We are biotechnology professionals with a broad range of expertise in pharmaceutical development including analytical, formulation and process development, scale-up and technology transfer. We specialize in gene therapy and biologics manufacturing, and can support oligonucleotide and small molecule programs, from pre-clinical development to commercialization. We offer guidance on topics including Regulatory Strategy, Analytical Characterization, Quality Systems, Risk Management, Process and Formulation Development, and strive to foster science-focused innovation.
After graduating from Stanford and MIT, our founder spent 30 years in the biopharmaceutical industry, the last 16 years as an executive leading Technical Development and Quality organizations. The experience of working on multiple clinical candidates and contributing to the approval of 8 commercial products inspired this consultancy, whose mission is to streamline the development and approval process for novel biotechnology modalities
We will think deeply about your problems and offer guidance customized to your modality, therapeutic area and patient population. While we don’t believe in cookie-cutter solutions, our track record of getting products to commercialization provides a great basis for our recommendations. We stand behind the quality of our work and won’t take on projects if we don’t have the right expertise.
We bring a unique combination of technical and regulatory expertise in a broad range of therapeutic modalities, as well as uncompromising integrity: we can help you get the science right and avoid compliance and regulatory mistakes.
Lucid Biotechnology Advisors LLC
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