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
SAJE CONSULTING SERVICES PRESENTATION
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