Quality Assurance

Quality is a requirement that no company in the medical, pharmaceutical or energy industry can afford to pass up. 

We know your high standard of requirements. For this reason our services must fulfill the most stringent demands.                                

PQS consults in implementing an appropriate quality system or in maintaining a clients Quality Management System (QMS). Core processes are monitored by Key Performance Indicators and control over the company objectives is ensured.

PQS provides the following services:

• Establish GMP Quality System
• Review QA Procedures, Master Production Instructions, Batch Records
• GMP Auditing- US, international
• Training
• FDA Inspection Response
• Corrective Actions, Preventive Actions
• Technology Transfer
• Product Development Reports preparation
• Preparation / Review of Chemistry, Manufacturing & Controls (CMC) Dossiers -
• Drug Master File
• QA of Scientific Reports, Clinical, Preclinical and Manufacturing Data
• Equipment, Utilities Qualifications, Validations
• Test Method Validation Protocols
• Product/ Process / Analytical Methods Review
• Preparation for Pre-Approval Inspections
• Technical Agreements / Quality Contracts
• Post Market Surveillance