Consulting Services

Integrated Compliance Solutions for the Life Sciences Industries

SeerPharma offer internation quality management, GxP experience and practical advice to support compliance management and productivity improvement across the life sciences industries:

• Quality Assurance and GxP Compliance Services
• Validation Services
• Risk Management Services
• Productivity Services

Quality Assurance and GxP Compliance Services

• Quality Management Systems - development, implementation and upgrades
• New facility GMP, GDP and GLP licensing, quality assurance and validation support
• Pre and post regulatory audit support
• GMP, GDP, GLP and GCP company wide compliance upgrades
• Risk assessments, audits and gap anaylysis to all international regulatory standards
• Implementation services to deliver risk mitigation plans

Validation Services

• Developing Validation Master Plans
• Writing validation documentation (plans, protocols, reports)
• Performing validation oversight and quality assurance services
• Conducting computer system GAMP compliance gap analysis
• Providing 21 CFR Part 11 assessments and remediation
• Implementing effective validation training programs
• Developing IT governance procedures
• Conducting validation according to intended use
• Recommending risk based validation strategies

Risk Management Services

• Risk management master planning
• Risk management training for all GxP needs
• Implementing the principles of ICH Q9
• Integration of risk management into corporate quality assurance systems
• Gap analysis using risk assessment
• Development of appropriate quality risk management tools

Productivity Services

• Productvity analyis and process improvement services
• Lean manufacturing audits
• Project management
• Productivity audits
• Workflow automation
• Enterprise IT integration

We deliver Confidence in Compliance

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