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Pharmaceutical industry


Equipements processes and utilities

From URS to qualification & launch and operation

Technical study on phases of Concept Engineering - Basic Engineering - Detail Engineering:

  • Processes
  • Mechanics
  • Electricity / Automation (GAMP5) / Instrumentation
  • HVAC

Mise en service :

  • Suivi d’installation
  • Exécution des protocoles
  • Troubleshooting

Production support and continuous improvement


Formulation / Manufacturing process

From Development of active ingredients to Pharmaceutical drug product for clinical and commercial phases.

  • Formualtion and pharmceutical conditioning
  • Tansfer :
    • Industralisation and scale-up: from laboratory- or pilot-scale to commercial manufacturing
    • Externalisation/outsourcing towards CMO...
  • Validation support/expertise, process optimisation

Qualification/ validation

Equipments, process and utilities

  • Equipment or utilities qualification: :
    • Risk analysis (FMECA)
    • Protocol writing (DQ/IQ/OQ/PQ)
    • Protocol execution
    • Report writing
  • Process Validation
  • Cleaning and sterilization Validation (CIP/SIP/COP)
  • Computarized system Validation (CSV)

Quality support for R&D or production

  • Qualitiy management system
  • Quality Asssurance (QA):
    • Operational QA: CAPA, deviation, change control, batch records review, investigations...
    • Supplier QA
    • Compliance
    • Review and approval of protocols for qualification and validation
  • Quality Control (QC):
    • Development/ Validation/ Analytical method transfer
    • Stability follow-up and trending
    • Laboratory equipment qualification

Regulated environment: GMP, GDP, GLP, ICH regulation

  • Regulatory strategy for all health related product and regulatory requirements adapted to each country
  • AMM file writing in CTD/eCTD formats (module 1 to 5) in national, centralized (CP), Decentralized (DCP) or Mutual Recognition (MRP) procedures
  • File submission, registration follow-up, answer to health autorities questions
  • Regulatory maintenance (Module 3 update, variation, renewal, transfer, DMI)
  • CEP/ASMF (Certificate European Product/ Active Substance Master File) writing and support
  • Packaging, labelling and artworks (RPC and manual translation...) validation
  • Promotional elements writing and verification
  • Strategy/market access and registration (CE marking) for medical devices
  • Regulatory support for clinical trial
  • Regulatory watch

  • Engineering Project management Engineering: new works or revamping
    • Infrastructures & buildings
    • Utilities (EPU, EPPI, steam ...)
    • Equipment (formulation, filling, packaging including serialization-aggregation)
  • Construction phase: technical coordination and execution follow-up
  • R & D project management: process development & formulation
  • Planning - Cost Control - Project Purchasing
  • Hygiene Safety Environment (HSE): work monitoring, occupational risk management
  • Quality project management: audit preparation, upgrading of a quality system

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