General Capabilities Overview

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Kymanox General Capabilities

Development & Operations

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Product Development

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Process Development

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Pharmacovigilance

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Chemistry, Manufacturing, & Controls

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Analytical Sciences

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Human Factors Regulatory & Strategy

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Packaging Technology & Engineering

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Manufacturing Science & Technology (MS&T) and Supply Chain

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Supply Chain Resiliency

Quality, Regulatory, & Compliance

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PAI Readiness

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Quality Assurance & Compliance

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Quality Management Systems

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Quality Auditing

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Complaints & Deviations

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EU GMP Annex 1 Guidelines

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Corrective and Preventive Actions (CAPAs)

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Quality Engineering

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Quality Control

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Regulatory Affairs

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Clinical Affairs

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Microbiology, Environmental Monitoring, & Personnel Monitoring

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Good Clinical Practices

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Good Laboratory Practices

Commissioning, Qualification, & Validation

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Computer System Validation

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Automation Engineering

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Analytical Method Validation

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Validation (CQV)

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Cleaning Validation

Strategy, Planning, & Execution

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Project Management

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Digital Transformation Services

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Digital Health

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Technology Transfer

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Innovation Solutions

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ERP Regulatory Compliance

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SAP Regulatory Compliance

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Laboratory Informatics

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Strategic Staffing Solutions

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Digital Maturity Assessment

Device Design and Innovation

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Laboratory and Testing

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Sterilization Engineering

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Drug Delivery Device Design

Markets

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Combination Products

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In-Vitro Diagnostics (IVD)

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Medical Devices & Risk Management