Projects Performed Under
Contract Include:
- Evaluation of in-house analytical and bioanalytical laboratories
- Evaluation of contract toxicology, pathology, and analytical laboratories
- Audits of contract facilities in the United States, Canada and Europe
- Preparation and review of Standard Operating Procedures
- Preparation of preclinical programs for FDA and corporate sponsor audits
- Investigation and remediation of problem studies
- Quality assurance staffing support for staff on medical leave
- Assistance to in-house Quality Assurance and technical staff in meeting
project deadlines
- Technical and regulatory training
- Preparation of responses to FDA-483 observations
- Taught courses and seminars in GLP regulations and regulatory audits
- Invited speaker for courses sponsored by RAPS (Regulatory Affairs
Professional Society)
- Special Session presentation on GLP regulations at the 2003 AALAS
National Meeting
- Participated in method transfer and technology transfer of manufacturing
processes
- Participated in the preparation for successful AAALAC facility
inspections
- Technical writing assistance for New Drug Applications and Common
Technical Documents