Business Details
19 Years
experience
Expert CMC Pharmaceutical Consulting Services
Live Oak Pharmaceutical Consulting has been a trusted partner in the pharmaceutical industry since 2007, specializing in Chemistry, Manufacturing, and Control (CMC) and non-clinical consulting services. Our team, led by Principal James Bernstein with 25 years of industry experience, provides strategic guidance from pre-clinical development through market registration. We offer comprehensive due diligence, regulatory document authoring, and oversight of analytical and formulation development. Our expertise extends to navigating Japanese pharmaceutical regulations and integrating CMC strategies with clinical development. With a network of seasoned associates, we deliver phase-appropriate solutions for drug substance and product development.Our track record includes successful FDA interactions, DMF submissions, and Pre-Approval Inspection preparation. We prioritize client value by solving complex development challenges while maintaining compliance with global standards. Our services encompass stability studies, method validation, and supply chain management tailored to pharmaceutical needs. We are committed to advancing drug development efficiency while ensuring patient safety and regulatory compliance. Our Raleigh-based team combines deep technical knowledge with practical problem-solving to support pharmaceutical innovation.
Services
CMC Strategy
Regulatory Consulting
Non-Clinical Development
Drug Formulation
Method Validation
Stability Studies
FDA Compliance
Due Diligence
Supply Chain Management
Pharmaceutical Training
Details
- Year established: 2007
Highlights and features
- We offer 25+ years of pharmaceutical CMC expertise from our principal consultant
- Our network includes associates with 10-25 years of specialized pharmaceutical experience
- Proven success in FDA-regulated drug development and regulatory submissions
- Specialized knowledge of Japanese pharmaceutical market requirements and compliance
- Comprehensive support from pre-clinical development through market registration
Services
CMC Strategy
We develop comprehensive Chemistry, Manufacturing, and Control strategies that integrate with clinical development timelines. Our approach ensures regulatory compliance while optimizing drug substance and product development. With expertise in FDA requirements and international standards, we help clients navigate complex pharmaceutical challenges from pre-clinical stages through market approval.
Regulatory Consulting
Our regulatory experts provide strategic advice for FDA interactions, DMF submissions, and Pre-Approval Inspections. We specialize in creating compliant documentation, reviewing analytical data, and developing submission strategies that meet both US and international regulatory requirements for pharmaceutical products seeking market approval.
Drug Formulation
We develop innovative drug formulations with expertise in sustained release technologies and biopharmaceutical property optimization. Our team solves formulation challenges through scientific analysis of polymer behavior, stability testing, and selection of appropriate delivery platforms to ensure effective pharmaceutical products.
Method Validation
We establish validated analytical methods for drug substance and product testing, including stability studies and impurity analysis. Our approach ensures accurate measurement of critical quality attributes while meeting regulatory requirements for method performance and data integrity in pharmaceutical development.
Due Diligence
We conduct comprehensive technical evaluations of drug candidates, including on-site assessments and document reviews. Our due diligence services identify development risks, support partnership decisions, and provide strategic recommendations for advancing pharmaceutical compounds through the development pipeline.
People
James Bernstein
Principal Consultant
Dr. Bernstein brings 25+ years of pharmaceutical industry experience, with expertise in CMC strategy, regulatory compliance, and drug development. He founded Live Oak Pharmaceutical Consulting in 2007 after serving as a pharmaceutical development manager at GlaxoSmithKline.
Questions
What pharmaceutical consulting services do you specialize in?
We specialize in Chemistry, Manufacturing, and Control (CMC) consulting, regulatory strategy, drug formulation development, method validation, stability studies, and FDA compliance guidance for pharmaceutical companies.
How do you support international pharmaceutical development?
We provide specialized expertise in Japanese pharmaceutical market requirements, including bio-equivalence standards, regulatory differences, and cultural considerations for global drug development programs.
What experience do your consultants have?
Our principal consultant has 25+ years in pharmaceutical CMC development, with associates offering 10-25 years of specialized experience in areas like analytical development, process validation, and regulatory submissions.
How do you handle complex drug development challenges?
We provide phase-appropriate solutions for challenges like genotoxic impurity analysis, sustained release formulation stability, and method development using industry-leading scientific expertise and problem-solving approaches.
What regulatory services do you offer?
We support FDA interactions, DMF submissions, Pre-Approval Inspections, regulatory document authoring, and compliance strategy for pharmaceutical products seeking US market approval.
