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
