Pharma

What can we do to detect illness before the person actually becomes ill? That is medicine’s challenge for the future.

Towards predictive and individualised medicine.

agap2 Pharma expertise

  • Our agap2 team is segmented into 5 groups. Each group contributs with its knowledge and expertise to every project development stage from inception to completion. Our consultants speak english, german and french.

Areas of expertise

Field of application

  • Writing specifications and data sheets
  • Basic engineering / Detail engineering (process engineering, electricity, instrumentation, piping, boilers, etc.) / Design review
  • R&D: biology / chemistry
  • Clinical studies: CRAs, clinical study management, biostatistics, data management
  • Industrialization / Process development
  • Technical inspection of materials and equipment
  • Early and late stage development 

References and technical expertise

  • Process detail engineering for new biotech plants
  • Process expertise for packaging production lines
  • Automation of production lines
  • Clinical study management: childish pulmonary hypertension
  • Detail engineering of a nanofiltration unit – Neuchâtel
  • Feasability studies / Basic design phases for a new vitamines production

FIELD OF APPLICATION

  • Quality assurance
  • Quality control
  • Regulatory affairs/ Regulatory monitoring
  • Quality Management

References and technical expertise

  • Quality Assurance, change management for finished and packaging lines
  • Analytical method development for raw material identification
  • Change control management for regulatory SCM linked to regulatory affairs
  • Continuous improvement Quality Control Laboratory
  • QA Project Management : implementation of trackwise in the stability department
  • CMC regulatory manager
  • QA for new API development, risk analysis for crossed contamination
  • Remediation for suppliers QA

FIELD OF APPLICATION

  • Supplier sourcing
  • Tendering
  • Technical validation of bids
  • Contract management, negotiation
  • Supplier expediting
  • Technical inspection of equipment before delivery
  • Logistics management / Industrial transport
  • 5S / Kaizen / TPM continious improvement, sotck management
  • Lean Management/ Manufacturing 6s

References and technical expertise

  • Streamline of a panel of service providers
  • Negociation with suppliers and contract writing for pharmaceutical developments
  • SCM for clinical trials
  • Purchase of technical equipment for a new product line but also for the engineering and maintenance department
  • Lean manufacturing TPM and 5S projects implementation

FIELD OF APPLICATION

  • Site work supervision, On-site installation
  • Equipment qualification, FAT/SAT/IQ/OQ/PQ (process, utilities, IT)
  • Process validation (manufacturing, cleaning, sterilization)

References and technical exptertise

  • Qualification of QC systems
  • Coordination between engineering and site for clean rooms revamping
  • Qualification of encapsulation equipment (IQ-OQ-PQ/FAT-SAT) 
  • Validation of cleaning process: washing and CIP/SIP for solid and liquid form 
  • Process validation at manufacturing scale (GMP – statistics studies) for biotechnology production 
  • Cleaning and sterilization process validation
  • Project Leader: Construction of new production lines 

FIELD OF APPLICATION

  • Product/Project/Program Manager (PMI or IPMA certified if needed)
  • Project Management Office: Cost
    control/Planning/Risk Management
  • Technical Project Manager
  • Project Quality Management (global, QA, QC)
  • Life Cycle Management

References and technical expertise

  • Quality management of CMO
  • Management of a risk analysis (FMECA) for Chemops, PU in Switzerland and abroad
  • Regulatory affairs management for change control in biotech manufacturing
  • Daily business in QA department for E-Compliance (CSV expert)
  • Files to register a new medicine abroad
  • Project of technology transfer of the fill-finishing activities towards an American production site
  • Project leader : automation – revamping production lines
  • Project management in life cycle management team

They trust us

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