Regulatory Activities

• Interpretation of FDA and international regulations and guidelines
• Represent company at FDA or other regulatory agency meetings
• Develop, review and assess FDA submissions: IND, NDA, ANDA, PLA, DMF, IDE, PMA

Scientific Management of CMC Development Programs

• API (Active Pharmaceutical Ingredient) research and development
• Analytical chemistry; assays and specifications, stability studies
• Formulation of dosage forms
• Manufacturing and packaging of clinical trial materials
• Scale up and commercialization

GMP Compliance Assessments and Audits

• Due diligence audits of prospective CMC contractors (qualification audits)
• GMP compliance assessments
• SOP and Documentation assessments

Quality Assurance

• Provide expert advice on all aspects of CMC Quality Assurance
• Review and write standard operating procedures (SOPs) to assist you in meeting relevant regulatory requirements
• Conduct training to support current Good Manufacturing Practices (cGMP) and compliance with CMC regulatory requirements
• Review protocols for method transfer, method validation, stability studies, and process validation