Quality Systems are critical to assuring safety, business reliability, and reputation, and even optimizing efficiency and cost-effectiveness over the long run. The establishment, maintenance, and assurance of a robust Quality Management System are essential to optimizing product approval success and maintaining regulatory compliance. An inadequate quality system can result in costly investigations, remediations, loss of product, and even business closure. PharmaAnalytic has a proven history of establishing successful and robust Quality Management Systems through their creation, remediation, oversight, assurance, and training.
Auditing & Gap Assessment
Analysts, knowledge & Skills
Laboratory facilities, equipment, techniques
Programs
Analytical method development and validation
Advise / support general method development strategies
Expediting specific method development
Advise / support method validation
Dissolution science program optimization
Evaluate / audit instrumental systems, methods and practices
Advise / support for general dissolution practices & strategies
Advise / design / support an advanced dissolution program
Advise / support specific projects (DoE, QbD, IVIVR/C, BA/BE)
Instrumental / software qualification and validation
Project Management
Advise / support CMC portion of product development
Advise / support needed analytical resources
Problem solving and research support
Analytical Dissolution and Product Development
Advise / support specialized research projects / studies
Advise / support time critical projects
Remediation
Technical Reports
APR, CMC sections, DMF, DHF, procedures, protocols, summary reports, SOPs, white papers, etc.
Technical transfers
Analytical Methods
Training