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At ProMediks Inc., we deliver a powerhouse of expertise across Validation Engineering, Project Management, Quality Engineering, and more, empowering your organization to achieve excellence. Our dedicated team transforms challenges into opportunities, ensuring every project exceeds industry standards and drives innovation.

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From Manufacturing and Packaging Engineering to Regulatory Affairs and EHS, we have the resources to enhance operational efficiency and foster sustainable growth.

Staff Augmentation

The service enhances organizational capabilities by providing specialized professionals who can quickly address project demands and fill critical skill gaps. This service ensures that teams are equipped with the necessary expertise to maintain operational efficiency and achieve successful project outcomes. Emphasis is placed on seamlessly integrating these resources into existing teams to support specific project needs.

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  • Skill Assessments

  • Talent Acquisition

  • Onboarding and Integration

  • Performance Management

  • Staffing Solutions

  • Knowledge Transfer

  • Project Specific Training

  • Continuous Support

Project Engineering

Services focus on the technical execution of projects, ensuring that all engineering aspects align with project specifications and industry standards. By applying engineering principles to project planning, design, and implementation, we help organizations bring their technical visions to life while optimizing resources and managing complexities. Key aspects of our Project Engineering services include:

  • Detailed Project Design

  • Technical Oversight

  • Resource Optimization

  • Problem-Solving and Troubleshooting

  • Risk Assessment and Mitigation

  • Testing and Validation

  • Cross-Functional Collaboration

Validation Engineering

Focus on ensuring compliance and performance through a structured approach to validation processes. This includes developing comprehensive documentation and executing testing to verify that systems, processes, and products meet required standards. Emphasis is placed on meticulous planning, execution, and adherence to best practices to guarantee safety and quality in all deliverables.

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  • ​User Requirements Specification (URS)

  • Software Requirements Specification (SRS)

  • Factory Acceptance Test (FAT)

  • Site Acceptance Test (SAT)

  • Change Control (CC)

  • Documentation Control (DC)

  • Master Validation Plan (MVP)

  • Installation Qualification (IQ)

  • Test Method Validation (TMV)

  • Design of Experiments (DOE)

  • Software Validation (SWV)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

Quality Engineering

Services for manufacturing focus on ensuring that production processes and products meet rigorous quality standards and regulatory compliance. By implementing systematic approaches and best practices, these services help manufacturers enhance product reliability, increase efficiency, and reduce costs associated with defects and non-compliance. Key components of our Quality Engineering services include:

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  • Quality Planning

  • Process Improvement

  • In-Process Quality Control

  • Corrective and Preventive Actions (CAPA)

  • Root Cause Analysis (RCA)

  • Statistical Process Control (SPC)

  • Compliance Audits

  • Supplier Quality Management

Project Management

Services provide comprehensive oversight and coordination for projects from start to finish, ensuring that every aspect is delivered on time, within budget, and to specification. With a focus on strategic planning, resource allocation, and stakeholder communication, we streamline project delivery and help organizations achieve their objectives. Key components of our Project Management services include:

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  • Strategic Planning and Scheduling

  • Budgeting and Cost Control

  • Team Coordination and Leadership

  • Stakeholder Engagement

  • Risk Management and Mitigation

  • Quality Assurance

  • Project Tracking and Reporting

  • Post-Project Evaluation

Manufacturing Engineering

Focus on optimizing production processes, enhancing product quality, and improving operational efficiency across manufacturing environments. By applying engineering principles and innovative solutions, these services help organizations streamline operations, reduce costs, and increase competitiveness. Key components of our Manufacturing Engineering services include:

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  • Process Design and Optimization

  • Production Planning and Scheduling

  • Automation Solutions

  • Quality Assurance

  • Tooling and Equipment Design

  • Cost Reduction Strategies

  • Supply Chain Collaboration

  • Training and Development

  • Sustainability Initiatives

  • Continuous Improvement

Packaging Engineering

Services to optimize packaging processes for both existing and new production lines, ensuring that products are safely and efficiently packaged to meet market demands and regulatory requirements. By applying engineering principles and innovative solutions, these services enhance packaging performance, improve product protection, and drive operational efficiency. Key components of our Packaging Engineering services include:

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  • Packaging Design Optimization

  • Process Improvement for Existing Lines

  • New Line Development

  • Material Selection

  • Regulatory Compliance

  • Automation Solutions

  • Testing and Validation

  • Supply Chain Coordination

  • Sustainability Initiatives

  • Training and Support

  • Continuous Improvement

Product Transfer

Services ensure the successful transition of products from one stage of development or production to another. This process maintains quality and compliance standards throughout the product lifecycle. Key components include:

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  • Transfer Planning

  • Validation and Compliance

  • Change Control Management

  • Cross-Functional Collaboration

  • Post-Transfer Evaluation

Supplier Quality Engineering

Services focus on ensuring that materials and components supplied by vendors meet rigorous quality standards and specifications. By employing engineering principles and quality management practices, these services enhance supplier performance, mitigate risks, and ensure that products meet customer requirements. Key components of our Supplier Quality Engineering services include:

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  • Supplier Qualification

  • Quality Assurance Protocols

  • Incoming Inspection and Testing

  • Root Cause Analysis (RCA)

  • Performance Monitoring and Reporting

  • Supplier Development

  • Risk Assessment and Management

  • Compliance Audits

  • Supplier Performance Reviews

  • Documentation and Traceability

  • Collaboration on Continuous Improvement

New Product Introduction

Services facilitate the successful launch of new products from concept to market. This comprehensive process ensures that products meet customer needs, regulatory requirements, and quality standards while maximizing market impact. Key components of our NPI services include:

 

  • Product Design and Development

  • Testing and Validation

  • Regulatory Compliance

  • Production Planning

  • Launch Strategy

  • Training and Support

  • Post-Launch Evaluation

Technology Transfer

Services facilitate the seamless transfer of knowledge, technologies, and capabilities between organizations or stages of development. This process ensures that innovative technologies are effectively integrated into operational processes, promoting efficiency and maximizing value. Key components include:

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  • Knowledge Assessment

  • Documentation Revision and Development

  • Validation Protocol Development

  • Validation Protocol Execution

  • Training and Support

  • Risk Assessment and Management

  • Performance Monitoring

Remediation

Services focus on identifying and addressing issues within processes, systems, or facilities to ensure compliance, enhance efficiency, and minimize risks. This structured approach helps organizations resolve problems effectively while maintaining operational integrity. Key components of our Remediation Project services include:

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  • Issue Identification

  • Root Cause Analysis

  • Regulatory Compliance Review

  • Action Plan Development

  • Implementation Support

  • Training and Awareness

  • Monitoring and Reporting

  • Documentation and Record Keeping

  • Post-Remediation Review

Operations Sustaining Support

Services are designed to maintain and enhance the effectiveness of your ongoing operations, ensuring consistency in performance and readiness for new project demands. With a focus on supporting day-to-day activities and driving continuous improvement, our services provide structured support to keep operations running smoothly. Key components include:

  • Driving Operations Meetings

  • Performance Metrics Creation and Delivery

  • Project Readiness Assessments

  • Continuous Process Improvement

  • Risk Management and Issue Resolution

  • Resource Allocation and Planning

  • Documentation and Compliance Support

Human Resources

Services are designed to support organizations in building and maintaining a skilled, engaged, and productive workforce. With a focus on both operational excellence and strategic alignment, our services cover the entire employee lifecycle, ensuring that HR practices effectively meet organizational needs. Key components of our Human Resources services include:

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  • Talent Acquisition and Recruitment

  • Employee Development and Training

  • Performance Management

  • Compensation and Benefits Administration

  • Employee Relations and Engagement

  • HR Compliance and Risk Management

  • Workforce Planning and Succession Management

  • Diversity, Equity, and Inclusion (DEI) Initiatives

  • Employee Wellness Programs

  • Data-Driven HR Insights

Construction Management

Focus on overseeing and coordinating construction projects from inception to completion, ensuring they are delivered on time, within budget, and to the required quality standards. This comprehensive approach enhances project efficiency and mitigates risks throughout the construction process. Key components of our Construction Management services include:

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  • Project Planning

  • Design Coordination

  • Procurement Management

  • Budget Management

  • Schedule Management

  • Quality Control

  • Risk Management

  • Safety Management

  • Stakeholder Communication

  • Project Closeout

Regulatory Affairs

Services are designed to guide organizations through complex regulatory landscapes, ensuring compliance and facilitating successful product approvals across various markets. With expertise in regulatory strategy, documentation, and submissions, our services help organizations meet industry standards and accelerate time to market. Key components of our Regulatory Affairs services include:

  • Regulatory Strategy and Planning

  • Regulatory Submissions and Approvals

  • Compliance Management and Monitoring

  • Labeling and Packaging Compliance

  • Risk Management and Mitigation

  • Regulatory Audits and Inspections Support

  • Post-Market Surveillance and Reporting

  • Regulatory Documentation and Dossier Preparation

  • Quality System Integration

  • Training and Regulatory Awareness

Reliability Engineering

Services ensure that systems, processes, and equipment operate consistently and effectively over their intended lifespan. By applying engineering principles and methodologies, these services aim to enhance performance, minimize failures, and increase overall operational reliability. Key components of our Reliability Engineering services include:

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  • Failure Analysis

  • Reliability Testing

  • Predictive Maintenance

  • Risk Assessment

  • Design for Reliability

  • Performance Metrics Development

  • Life Cycle Analysis

  • Root Cause Failure Analysis (RCFA)

  • Training and Development

  • Continuous Improvement

  • Asset Management

EHS

Services are designed to help organizations create and maintain safe, compliant, and sustainable workplaces. By integrating regulatory compliance with proactive safety and environmental management, we support organizations in minimizing risks, ensuring employee well-being, and protecting the environment. Key components of our EHS services include:

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  • Regulatory Compliance Support

  • EHS Program Development

  • Risk Assessment and Management

  • Training and Awareness Programs

  • Incident Investigation and Reporting

  • Environmental Management

  • Health and Safety Audits: Conducting regular audits and inspections to evaluate EHS program effectiveness, ensuring adherence to policies, regulations, and best practices, and identifying areas for improvement.

  • Emergency Response Planning

  • Sustainability Initiatives

  • Occupational Health Services

  • EHS Performance Metrics and Reporting

Contact

Get in touch to learn more.

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