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Services

Product Development Strategic Planning

• Provide innovative regulatory and scientific product development strategies to streamline and expedite product development
• Design preclinical and clinical strategies consistent with overall product development plan
• Perform scientific and regulatory due diligence

Regulatory Experience

• Provide regulatory expertise for product development and regulatory approval
• Assist in document/presentation preparation for FDA meetings
• Attend FDA meetings with and on behalf of our clients
• Write, edit, and/or review all documents, including study reports, for regulatory submissions and briefing documents

Chemistry and Manufacturing

• Provide expertise, management and oversight for manufacturing and scale-up of drug products

Preclinical and Bioanalytical Services

• Develop strategies, develop and review protocols and manage preclinical pharmacology and toxicology studies and metabolism studies
• Provide expertise and oversight of bioanalytical assay development

Clinical Pharmacology

• Develop biopharmaceutics/PK/PD strategies as part of the drug development plan
• Design clinical pharmacology studies and substudies
• Perform PK analyses, including non-compartmental (NCAs) and population PK/PD analyses

Translational Science

• Provide expertise in bridging pre-clinical and clinical development
• Provide ongoing data analysis and interpretation to optimize identification of patients and dosage regimens to be evaluated
• Provide biomarker identification and analysis
• Perform PK/PD modeling

Clinical Research

• Design Phase 1-4 studies to achieve clinical and regulatory objectives
• Analyze safety and efficacy data from Phase 1-4 studies
• Provide knowledge and experience for the unique needs of any clinical program

Project Management

• Manage and provide oversight of product development programs including tracking of deliverables, budgets and timelines