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Our Services

VTSI is primarily a full-service GMP Compliance, Quality Systems, and Validation Consulting firm with areas of core expertise covering specific activities.  VTSI retains engineers, specialists, affiliates, project managers, and consultants with the required technical expertise and extensive practical working experience in different areas of our business.  The following table lists specific services VTSI can provide.

The real key to success remains on long-term relationships, a commitment to improve the cost and schedule performance of each successive project, and the institutionalization of best practices for the safe, high quality delivery of every project and program, regardless of size or location.

Area of Expertise Services Offered
Regulatory and Compliance Services

Regulatory Affairs and Compliance
  • Explanation of FDA regulations and expectations
  • Documentation, facility, and process assessments for compliance to US cGMP and other international standards
  • FDA consent decree issues
  • Third party review services
  • FDA Certification Audits
  • Risk Management Review and Risk Assessment Review

Audits and Inspections
  • Evaluation of Corporate Quality Management System
  • Inspection of the manufacturing facility
  • Facility and system design evaluation
  • Design and review of validation programs
  • Audit of validation studies (facility, systems, and process)
  • Due diligence audits and assessments
  • Procedure and documentation review
  • Master Batch Record review
  • Supplier and vendor quality program
  • Vendor audits
  • Contract Manufacturing Organizations (CMOs) audits
Quality Systems and Validation Services

Quality Systems and Validation Services
  • Quality system evaluation and development
  • Quality assurance oversight of contract services (manufacturing, testing)
  • Document system development and review
    • Controlled documents management program
    • SOP development and review process
    • Discrepancy and deviation reporting
    • Preventive Maintenance Program
    • CAPA (Corrective And Preventative Actions) and RARM (Risk Assessment and Risk Management)
    • Change control and management program
    • Validation policies, protocols, and reporting requirements
    • Drawings management program
  • Calibration and metrology program
  • Computer systems and software assessment and validation program
  • Data integrity and electronic records and signatures
  • Computer systems – Good Automated Manufacturing Practices (GAMP)

Validation and Manufacturing Quality Control
  • Development and review of CMC (Chemical and Manufacturing Controls) section of regulatory submissions
  • Process development and technology transfer
  • Manufacturing operations management
  • Validation, qualification, and optimization:
    • Overall validation program assessment
    • Validation project management
    • Preparation of validation master plans, validation protocols, and summary reports
    • Execution of validation protocols (IQ, OQ, and PQ)
    • Facility and utility systems qualifications
    • Process equipment qualification
    • Manufacturing process validation
    • Cleaning validation
    • Test methods validation
    • Computer systems validation
    • Analytical assay development assistance and assessment
    • Periodic Validation Reviews (PVR)
  • Identity, purity, potency, stability testing assistance and assessment
  • Development and implementation of calibration program
  • Development and implementation of preventive maintenance program
  • Development and implementation of change control and management program
  • Development and implementation of manufacturing quality system

Training
  • Review and assessment of current training programs
  • Development and implementation of training program
  • Development of training materials
  • Customized onsite or classroom cGMP training
Engineering Services

Process and Facility Design Engineering
  • Technology analysis
  • Process design specification
  • Equipment specification, selection, costing, and placement
  • Conceptual facility design
  • Facility, equipment, and process design review
  • Engineering and documentation system and construction review
  • Facility construction and equipment procurement management
Project Management Services

Project Management
  • Overall project planning, development of requests-for-proposal (RFP) and tender documents
  • Evaluation of proposals, recommendations, obtaining necessary client approvals for assigning the work
  • Selection of construction company, architect, structural engineering company, etc.
  • Development of timelines, budgets, and personnel requirements for start-up
  • Strategic planning of timeliness for approvals and licensing from local governing bodies to fulfill the business development plan
  • Development of timelines, budgets, and personnel requirements for technology transfer and manufacturing operations
  • Construction phase vendor management
  • Progress reporting and client feedback