Pharma & Biotechnology

GMP expertise for competently implemented customer projects

agap2 intervenes on Pharma & Biotechnology projects, from routine quality to qualification and validation to project management.

Our expertise

Discover our areas of expertise.

Research & development

  • Scientific research
  • Preclinical studies (toxicological studies)
  • Pharmaceutical and analytical development, galenics
  • Biostatistics
  • Project Management

Regulatory affairs

  • Clinical trials (clinical project management, clinical trials, clinical data management)
  • Biostatistics
  • Project Management
  • Regulatory Affairs (planning, coordination and implementation of marketing authorisations, publishing)
  • Medical affairs
  • Pharmacovigilance

Production

  • Process transfer
  • Scale-up
  • Plant purchase
  • Process optimisation
  • Qualification (laboratory equipment, production facilities, clean rooms)
  • Validation (methods, processes, cleaning, transport, compterized systems (CSV))
  • Lean management (SixSigma, 5S, Kaizen)
  • Contract management with Contract Manufacturing Organisations (CMOs)
  • Project management

Quality management

  • Quality control (method development and validation)
  • Quality assurance (GLP, GMP, GCP)
  • Quality system support (deviation, change, document management, complaints management, training, batch record review)
  • Inspection preparation (mock audits) and support during inspections by authorities
  • GMP compliance
  • Project management

Engineering, Procurement & Construction Management

  • Requirements and specifications (URS),
  • Basic and detail engineering,
  • Risk analysis,
  • Technical documentation,
  • Plant and process optimisation
  • Commissioning (FAT/ SAT)
  • Manufacturing Engineering
  • Clean room technology/ Technical building equipment/ HVAC
  • HSE Management
  • Project management (cost estimation and cost control, time and resource planning)
Our offer

Different levels of commitment.

Commitment to results.

Commitment to results is adapted to services for which the client wants agap2 to commit to fixed objectives. It is intended for projects defined in the specifications, for which agap2 proposes a cost calculation per task or project milestone. It allows the search for optimisation and productivity gains and is distinguished by invoicing by deliverables (tasks or milestones).

Resource commitment.

Resource commitment is the most common. It allows great flexibility and responsiveness. It is mainly intended for projects without specifications, with a scope that can change regularly. It is characterised by the invoicing of the time spent on the project.

How do we work?

Discover our intervention methods.

Our interventions aim to respond to our clients’ problems in the most accurate and appropriate way possible.

  • Temporary employment : Counselling on the current A√ú law | Flexible integration and easy adaptation of the activity | Operational support of the project manager | Invoicing of the hours worked according to the hourly rate
  • Service and consulting contract : Consultation in the elaboration of the project definition |¬†Independent implementation of the projects on site | Project documentation | Communication and project support | Invoicing of the hours worked according to the hourly rate
  • Contract for work : Detailed clarification of the assignment, stocktaking and preparation of the project concept | Project structuring with solution-oriented milestones | Communication and project support | Invoicing of the total order according with optional instalment payments according to the status of service provision
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