CONSULTING DIVISION

Validation: Our services in this area include development, review, execution, and approval of master plans, protocols, and summary reports. We provide comprehensive and high quality services in the following areas:

• Computer Software
• Computer Hardware
• Manufacturing Process
• Test Method
• Autoclave
• Refrigerator
• Freezer
• Lab Equipment
• Cold Chain
• Cleanroom
• Aseptic Process
• In-Situ Efficacy Evaluation of Disinfectants
• Incubator.

 

Auditing: Each experienced GXP Auditor in our organization conducts an average of forty audits each year in both medical device and pharmaceutical industries worldwide. Regulation and Standards covered include:

• GCP
• GLP
• GMP
• ISO 9001:2000
• ISO13485:2003
• Canadian Regulation (CMDR) and
• MDD
• AIMDD
• IVDD
  
  

Consent Decree Management: We provide cost effective solutions in handling statement of work under consent decree.

 

Training: We provide GXP training with certificates of training recognized by industry third-party auditors. Our training programs include:

• GXP Overview 
• Auditing Techniques and Guidelines
• CAPA Implementations
• OOS Investigations and Root-Cause Analysis
• Design Control
• Good Laboratory Practices
• Good Clinical Practices
• Good Documentation Practices
• Aseptic processing
• Validation
• ISO Registration Process
• Supplier Quality Implementation and Management.
• Quality Systems Architecture