agap2 assist you with setting up or upgrading your bio-tech production facilities.
All our areas of expertise.
Process and Manufacturing
Tech Transfer, Chemical, USP, DSP, F&F and DP process engineering, production planning and troubleshooting, equipment URS and sizing, single-use and continuous production, support to CQV, Process and Cleaning Validation, CMO tendering, selection and management.
New Facilities Design
CAPEX Leadership, Basic and Detail Engineering, Design and sizing of equipment, PFD and PID, HVAC, Utilities, layouting, isometrics and stress calculation, URS, Process engineering, HAZOP.
Construction
onstruction supervision, construction scheduling and cost control, safety audits, contractors’ management, EHS construction support, Revamping and Maintenance Support.
Electrical engineering and automation systems
Electrical engineering and automation systems: Electricity, industrial IT, PLC/HMI, DCS programming, Integrated Building Automation, Robotics, MES implementation and validation, MOMS.
Quality Assurance
Compliance, QMS, QA for Manufacturing, QA for Qualification and Validation, QA for QC, QA Suppliers Management, Audits, QA for Tech Transfer, Quality Training.
Quality Control
Raw Materials Testing, Physico-Chemical Analytics and Stability studies, RNA QC, Assays, Microbiology, Metrology, Audits, Troubleshooting.
Manufacturing / Production
GLP, GMP, ICH, European Pharmacopeia.
Regulatory affairs
FDA Registration/Submission, Module 1,3, CMC, Change control, Labelling.
CQV
- Preparation of CQV documentation (Risk analyses, Master plan, test, reports)
- Selection of suppliers URS
- Accompaniment of FAT and SAT
- Commissioning and Installation with IQOQPQ
- Computerized System Validation
Project Management
- Project planning and organization, project controlling and reporting, resource planning, cost estimation, project scheduling
- Serialization and Packaging
- Tech transfer
- Lean Manufacturing
- Flow management
1 - Quality support for routine activities for CSL Behring in Berne.
Optimize the qualification process for Analytical Laboratory Equipment and Analytical Computer Systems.
2 - CSV on Automated Systems for Merck in Aubonne.
Technical support for the validation of automated systems on a manufacturing site, including SCADAs, EMS, PLCs following the GAMP.
3 - CSV on Automated Systems for Merck in Aubonne.
Technical support for the validation of automated systems on a manufacturing site, including SCADAs, EMS, PLCs following the GAMP.
A dedicated solution for every single project.
We recommend the collaboration model best suited to your specific needs. Drawing on 10 years of experience in engineering services, we’ve developed two collaboration models.
Technical assistance: we provide resources to support your assignments, ensuring tremendous agility and rapid responsiveness, especially for projects whose scope can frequently change.
Commitment to performance: we work on site for projects lasting over three months whereby specific goals are defined.
