Innovation for healthcare

agap2 provide the support needed to ensure your pharmaceutical product manufacturing meets quality standards.

Our expertise

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 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
Our offer

•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.


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