127/Broadway Business Hub, Opp. to Bharat Petroleum Bhayali, Vadodara-391 410, Gujarat. India.
 

Quality

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.

  • Training
  • Programs
  • Remediation
  • Technical Reports
  • Project Management
  • Analytical Methods
  • Technical transfers
  • Auditing & Gap Assessment
  • Analysts, knowledge & Skills
  • Problem solving and research support
  • Advise / support method validation
  • Advise / support time critical projects
  • Dissolution science program optimization
  • Laboratory facilities, equipment, techniques
  • Analytical method development and validation
  • Advise / support general method development strategies
  • Expediting specific method development
  • 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
  • Advise / support CMC portion of product development
  • Advise / support needed analytical resources
  • Analytical Dissolution and Product Development
  • Advise / support specialized research projects / studies
  • APR, CMC sections, DMF, DHF, procedures, protocols, summary reports, SOPs, white papers, etc.