agap2 provide the support needed to ensure your pharmaceutical product manufacturing meets quality standards.
All our areas of expertise.
Process and Manufacturing
Tech Transfer, API, Galenic, Dry, Liquid and Sterile forms 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
Construction supervision, construction scheduling and cost control, safety audits, contractors’ management, EHS construction support, revamping and Maintenance Support.
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 (Commissioning, Qualification, Validation)
- 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 - Engineering support to the IBEX project for Lonza.
Feasibility studies and conceptual design of new biotech production facilities in Visp.
2 - Life Cycle Management and qualification for Cilag AG J&J in Schaffhausen.
Life Cycle Management and qualification of analytical lab equipment according to GMP.
Windows server remediation for computerised lab equipment.
3 - CSV on Automated Systems for Merck.
CSV on Automated Systems - Technical support for validation of automated systems on a manufacturing site, including SCADAs, EMS, PLCs following the GAMP.
4 - Management of DSP Production of Preclinical Batch for Novartis Klybeck.
Production campaign preparation in terms of equipment, raw materials, buffer, analyses. Managing the tech transfer from the process development lab. Writing the campaign report including quality and productivity analyses.
•Project planning and organization, project controlling and reporting, resource planning, cost estimation, project scheduling •Serialization and Packaging •Tech transfer •Lean Manufacturing •Flow management
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.
