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Below is a non-exhaustive list of subjects we work on with our partners.

  • Definition of the Qualification Strategy and validation master plan
  • Drafting documents : Quality and Qualification (Commissioning, Protocol, Studies)
  • Drafting / adaptation of protocols CQ/IQ/OQ/PQ
  • Execution of Qualification tests and management of non-conformities
  • Implementation of CAPA and Change Control
  • Supervision and realization of FAT/SAT
  • Drafting reports
  • Development of regulatory strategies
  • Drafting reports, submission and variations to health authorities
  • Validation of packaging items
  • Publishing
  • Drafting of technical files in compliance with regulations 2017/745 and 746
  • Performing Change Control and updating internal procedures
  • Study Supervision
  • Definition of the need and framing of the project
  • Drafting specifications
  • Planning
  • Consultation and choice of suppliers
  • Management of costs, quality, deadlines
  • Reception of equipment and monitoring of work
  • Preparation and support for audits of notified bodies
  • Implementation of Quality Management Systems
  • Drafting of CAPA, SOP, CC
  • Audits and supplier panel rationalization
  • Review, release, and recall of batches

CRA

  • Pre-selection, initiation, and closure visits to investigator sites
  • Control of the application of procedures and regulations regarding Monitoring and Safety
  • Drafting reports and archiving documentation
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Local and global clinical project manager

  • Design and implementation of clinical trials
  • Management of schedules, budgets, and resources
  • CRO oversight
  • Supply management and shortages anticipation
  • Planning (supply, production flow)
  • Inventory management
  • Sales Forecast
  • Logistics
  • Study, selection, and monitoring of subcontractors (CMO)
  • Transition management
  • PMO/Strategic program management

Studies

  • Definition and sizing of installations
  • Creation of P&IDs
  • Writing technical specifications, functional analyses analysis, and operating manuals
  • Participation in the choice of the technical solution
  • Managing interactions with suppliers

On-site :

  • Production monitoring
  • Improvement of manufacturing processes
  • Installations compliance
  • Risk analysis
  • Writing validation plans, traceability matrix and validation file reporting protocols
  • Organization of tests, monitoring of nonconformities
  • Support for periodicals reviews
  • Compliance (Data Integrity, 21 CFR Part 11, GAMP 5)
  • Samples management (Physical and documentary)
  • Analyses (Microbiology, Physicochemical, etc.) and stability studies according to ICH and USP
  • Transfer and validation of analytical methods (HPLC, UPLC, GC, etc.)
  • Monitoring of deviations and management of failures
  • Maintaining conformity, quality, and safety of premises and equipment
  • Establishing critical project path / planning
  • Definition of milestones
  • Tracking milestones, progress, and budget
  • Communicating about the schedule and the critical path with the project team
  • Deviation management
  • Reporting
  • Resolution of problems impacting compliance with the schedule (speeding up / slowing down)
  • Choice and implementation of project monitoring tools
  • Communication with various departments regarding the project
  • Tracking contracts, orders and deliverables
  • Creation of stakeholders mapping
  • Understanding Process Mapping
  • Communication plan development :
  • Internal and external
  • Online learning and digital training
  • Intranet
  • Inclusion of the topic in events planned by other speakers
  • Co-construction of change management with the stakeholders
  • Development of a training program with stakeholders
  • Identifying urgent short-term needs

As part of a project on a pharmaceutical site, the company is acting as project manager for the implementation of a new process and the revamping of all buildings linked to this project (STEP, Laboratory, Production, Maintenance….):

  • Production schedule management, identification of bottlenecks
  • Cost management of the different phases of the project, identification of critical points
  • Organization and follow-up of equipment receptions (mechanics, IQ/OQ/PQ)
  • Participation in technical choices 
  • Organization of steering and reporting ( KPIs) to the main project manager and participation to the steering committee
  • Participation in project meetings with various stakeholders (external engineering, HSE, Quality, Project Manager, Process and EIA study managers).
  • Ensuring the application of processes, standards, and requirements at all stages of the project.

As part of the reorganization and creation of a Packaging Life Cycle Management expertise centre , we created and managed it by :

  • Creation and management of an expertise center on Packaging Life Cycle Management
  • The Definition of a RoadMap
  • The mapping of resources, processes, and tools
  • The definition of objectives and their implementation
  • The Implementation of new tools
  • Setting up service assessments
  • Implementation of assessments on the service
  • The Change Management
  • The Team Management