Live Oak Pharmacy Consulting

At Live Oak Pharmaceutical Consulting, Inc., we are dedicated to providing premium quality consulting services to the pharmaceutical industry. With a mission to facilitate the efficient development of pharmaceuticals, our team of highly experienced professionals is committed to delivering exceptional results. Our expertise spans the range from due diligence and pre-clinical development to market registration, covering various aspects of Chemistry, Manufacturing, and Control (CMC) and non-clinical functions.

Our History

Founded in 2007, Live Oak Pharmaceutical Consulting, Inc. was established by Principal James Bernstein, Ph. D., who has over 25 years of experience in the pharmaceutical industry. With a background in CMC development, Dr. Bernstein brings a wealth of knowledge in managing and strategizing CMC development efforts. His extensive experience has given him a deep understanding of the pharmaceutical industry, from pre-IND to market registration.

Our Associates

At Live Oak Pharmaceutical Consulting, Inc., we have assembled a team of experienced associates who have demonstrated effectiveness in working on development teams. With extensive experience in their respective fields, our associates have a broad range of expertise, including CMC regulatory science and quality assurance, due diligence activities, analytical development, synthesis and process development, and auditing and GLP/GMP consulting.

Our Services

Our consulting services are designed to meet the specific needs of the pharmaceutical industry. Our expertise covers a wide range of services, including:

• CMC function leadership
• Project planning and budgeting
• Contract Development Organization selection
• Strategy for integration of CMC, clinical, and non-clinical development
• Solve development problems with phase-appropriate solutions
• Pharmaceutical Product Development
• Deliver clinical supplies to the project team
• Author and review regulatory documents
• Regulatory advice and services
• FDA interactions
• Regulatory submissions
• Submissions strategy
• SOP authoring and review
• Sourcing and oversight of synthetic, analytical, and formulation development
• Vendor selection, GMP auditing, and management
• Method development
• Synthetic process development
• Formulation development
• Stability studies

Our Approach

At Live Oak Pharmaceutical Consulting, Inc., we believe that success in drug development depends on a complete team of professionals. Our associates work together to provide superior consulting services, ensuring that our clients receive the best possible outcomes. We strive to be consultants that contribute real work and advance the project, rather than just proposing additional work for our clients.

Our Credentials

Our Principal, James Bernstein, Ph. D., has extensive experience in the pharmaceutical industry, with a background in CMC development. He has worked closely with some of the world's leading pharmaceutical companies, including GlaxoSmithKline.