Dr. Jay Breaux Ph.D, RAC, PMP
JB Life Sciences
7708 Amesbury Dr.
Chapel Hill, NC, 27514-9713
Phone:
(919) 408-0787
E-mail: jbreaux@nc.rr.com
Web Site: www.jblifesciences.com
Specialties:
- Pharmaceutical
- Regulatory Affairs
- Analytical
- Chemistry
- Manufacturing Controls (CMC) Consulting
Services:
JB Life Sciences provides CMC and CMC regulatory affairs consulting services.
I. Chemistry, Manufacturing, Controls Consulting Services
- Provide due diligence CMC audits for licensing candidates
- Prepare proposal requests and contractor selection criteria for outsourced projects
- Conduct audits of potential CMC contractors
- Act as liaison between sponsors and CMC contractors
- Oversee drug substance and drug product development and manufacture
- Coordinate formulation and drug product development
- Manage production of clinical trial material
- Coordinate drug substance and drug product analytical chemistry and stability studies
- Prepare and review analytical method development and validation protocols, status reports and final reports
- Manage genotoxic impurity analytical studies per new guidance
- Manufacturing and analytical troubleshooting
- Review and approve batch records and GMP documentation
- Conduct investigations of OOS results and batch failures
- Provide CMC and CMC regulatory expertise to project teams
II. CMC Regulatory Affairs
- Conduct gap analyses of CMC information available for INDs and NDAs
- Author, review and compile CMC/quality sections of IND, NDA, DMF and other regulatory submissions
- Prepare CMC sections of FDA meeting packages
- Provide regulatory guidance for the setting of drug substance and drug product manufacturing specifications
- Participate in FDA meetings
- Prepare responses to FDA questions
