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Quarentum's contribution to your goals

Development of CMC and Regulatory Strategy

  • Balance between regulatory requirements and data & document generation

  • Optimization of change management to minimize regulatory effort and consecutive changes

  • Transformation of CMC data into meaningful reports

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Optimize Business Processes & Quality Management Systems

  • Business process analysis and process standardization

  • Leveraging data to simplilfy processes and improve decision making

  • Lean and compliant SOP architecture

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Scientific Expert Guidance for

  • Interpretation of and compliance with specific guidelines and requirements

  • Dossier compliance: check of regulatory compliance of the current manufacturing practice against the registered dossier

  • Due diligences

Strategic Projects

  • Definition and execution of project charter and project plan

  • Workshop organization and stakeholder management

  • Management of budget and timelines

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Major Submissions

  • From change control over dossier preparation to deficiency letter handling

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IT Project Management

  • From project set-up over process and data analysis to user stories, system testing, training, and implementation

Process and Data Analysis

  • Identification of non-value adding process steps and loops

  • Optimization of use of available data

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System / Application Design

  • Definition of business needs vs "nice to have

  • Customization vs configuration vs process/organizational changes

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Creation of User Stories

  • Preparation and execution of sprints

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Master Data Governance & Management

  • Establishment of governance organization

  • Process and role definition to ensure high quality data

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IDMP Readiness

  • Implementation of IDMP standards

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Computer System Validation (CSV)

  • Inspection-proof CSV documentation

Technical Writing for

  • CTAs/INDs, NDAs/BLAs, Variations, and Renewals

  • IMPDs, Module 2.3 and 3 (Quality Overall Summary / Technical Registration Reports), ASMFs/DMFs,  and CEP applications

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Standard Operating Procedures (SOPs)

  • Restructuring and trimming your SOP landscape

  • Revision of existing SOPs and creation of new SOPs

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