Pallas Pharmaceutical Consulting LLC
Pharmaceutical Analytical Development
Product Development Support • QC Laboratory Operations • Stability
Program Management • Quality Assurance
Thirty
years’ experience supporting the pharmaceutical industry specializing in Analytical
R&D, Product Development, Laboratory Management, Quality Control and Quality
Assurance functions.
Consulting Services
 | Expert
method development, validation and troubleshooting support |
| Data
analysis and report review |
| Contract auditing
to evaluate laboratory technical quality and GLP / cGMP compliance |
| Analytical
laboratory work process evaluation |
| Product development project management services |
| Training
programs (HPLC, general analytical techniques, and quality topics) |
| Preparation
of documentation for CMC Sections of FDA regulatory filings |
| Assistance
for inspection concerns and support for FDA general or pre-approval
inspections |
Establishing
New Analytical Capabilities for Emerging Companies
|
Establishment of R&D and QC laboratory functions |
|
Establishment of Quality Control / Quality Assurance systems |
|
Development
of Standard Operating Procedures |
|
Evaluation and specification of analytical equipment requirements |
|
Defining
qualification requirements for analytical equipment and computerized data
systems |
|
Organizational and staffing development |
|
Training
program development and presentation |
|
Development
of programs for QC testing and stability |
| Document control and record retention systems |
Education
and Training
|
Six years' experience in teaching General College Chemistry and Chromatography courses. |
|
HPLC training can be customized to your organizations requirements. |
|
General and Analytical Chemistry tutoring for High School or College is available in the Colorado Springs area. |
All services are tailored to meet specific client requirements. Consulting can be provided on an advisory capacity or as a temporary hands-on extension of your management team.
