SCIENCE-BASED, PHASE APPROPRIATE PRODUCT DEVELOPMENT STRATEGIES

• Provide science-based product development strategy from concept to registration and approval
• Alignment of development strategies with development phase, plans, and timelines
• Regulatory assessment and risk management of CMC activities to enable efficient product development
• Leadership and mentoring of cross functional teams to promote collaboration and team-based product development
• Scientific staff development and training

REGULATORY STRATEGIES

• Global regulatory submissions and issues (US, EU, Canada, Australia, China, Japan, Asia)
• IND, CTA, NDA and MAA writing and review

CLINICAL PERSPECTIVES

• Clinical operations and review
• Initial clinical trial designs and protocols

FORMULATION DEVELOPMENT AND MANUFACTURING

• Design of phase appropriate stability studies
• Formulation strategies for toxicological and early clinical studies
• Formulation and delivery platform design based on molecule properties and available in vivo data
• Material and vendor selection for excipients
• Assessment of CMC specifications and critical quality attributes
• CMC manufacturing, packaging and labeling and facilities operations
• State of California license as Pharmacist Designated Representative for wholesale operations for distribution of dangerous drugs or dangerous devices

ANALYTICAL DEVELOPMENT

• Analytical and Genotoxic Impurity Control, ICH M7 interpretation and implementation of strategies
• Extractables and Leachables
• Method development, validation and transfer
• Specifications, critical quality attributes and quality by design
• Design of stability studies and statistical analysis
• Bioanalytical method and validation protocol writing and review for nonclinical and clinical studies

PRODUCT CONCEPT EVALUATION

• Technical assessment and recommendations
• Preformulation and excipient compatibility study design
• Solid-state data evaluation and interpretation
• Amorphous dispersions for dissolution-limited compounds
• Formulation and delivery platform selection based on molecular properties
• Development of target product profile
• IP strategy development
• Patent reviews and evaluation of technical landscape
• Development of life cycle management opportunities

DRUG DELIVERY/TECHNOLOGY ASSESSMENT

• Provide clients with CMC support for due diligence activities
• Evaluation of drug delivery technologies to support product or platform acquisitions at any stage of product development
• Formulation and delivery platform evaluation based on molecular properties and preclinical/clinical data
• Assessment of drug delivery strategies based on molecular properties and unmet medical need
• Development strategies for: oral controlled release and immediate release products, pulmonary and aerosol drug delivery products, and parenteral products and platforms
• Solubilization and prodrug strategies