Early Drug Development Group (E2DG)

www.e2dg.com

We offer professional support all along the drug development life cycle, from lead optimization to Phase I clinical trials in oncology. We optimize and accelerate your R&D programs, based on our drug positioning-oriented philosophy. Early Drug Development Group is focused on building partnerships and strategic alliances with academic research institutions, universities, governmental agencies, small size biotechnology partners and investment funds. COLLABORATION WITH US IMPROVES YOUR RESOURCES INVESTMENT AND STRENGTHENS YOUR EARLY DRUG DEVELOPMENT PROGRAM IN ONCOLOGY. YOUR KEY BENEFITS • Assistance on preclinical, pharmacological and CMC approaches, clinical studies design, regulatory strategies and trials implementation to optimize and accelerate oncology R&D programs through our strong medical input and oncology-experienced staff. • Optimization, management and execution of an efficient, customized and cost-effective development program of novel drugs through access to a highly skilled and coordinated team of world-class R&D experts. • Broad capabilities in preclinical, pharmacokinetic and radio-pharmacology studies to guide clinical development. • Guidance on FDA/EMA regulation and IND submission. • Clinical Phase I study design and trial implementation. • Due diligences on chemistry, molecular pharmacology, ADME/PK and CMC areas. Independent medical review of clinical studies data. • Benefit from our strategic and hands-on involvement in projects which synergizes the best industry expertise with excellent cost-effective outsourced solutions to solve complex drug development challenges. • Management for the transfer of projects from academic to company environment. Evaluation of the financial costs of pursuing a full drug development program.

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We offer professional support all along the drug development life cycle, from lead optimization to Phase I clinical trials in oncology. We optimize and accelerate your R&D programs, based on our drug positioning-oriented philosophy. Early Drug Development Group is focused on building partnerships and strategic alliances with academic research institutions, universities, governmental agencies, small size biotechnology partners and investment funds. COLLABORATION WITH US IMPROVES YOUR RESOURCES INVESTMENT AND STRENGTHENS YOUR EARLY DRUG DEVELOPMENT PROGRAM IN ONCOLOGY. YOUR KEY BENEFITS • Assistance on preclinical, pharmacological and CMC approaches, clinical studies design, regulatory strategies and trials implementation to optimize and accelerate oncology R&D programs through our strong medical input and oncology-experienced staff. • Optimization, management and execution of an efficient, customized and cost-effective development program of novel drugs through access to a highly skilled and coordinated team of world-class R&D experts. • Broad capabilities in preclinical, pharmacokinetic and radio-pharmacology studies to guide clinical development. • Guidance on FDA/EMA regulation and IND submission. • Clinical Phase I study design and trial implementation. • Due diligences on chemistry, molecular pharmacology, ADME/PK and CMC areas. Independent medical review of clinical studies data. • Benefit from our strategic and hands-on involvement in projects which synergizes the best industry expertise with excellent cost-effective outsourced solutions to solve complex drug development challenges. • Management for the transfer of projects from academic to company environment. Evaluation of the financial costs of pursuing a full drug development program.

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