Life sciences

agap2 is active in the life sciences sector for projects in Pharmaceuticals, Biotechnology and Medical Devices.

Our competences

Discover our areas of expertise.

R&D of medical devices

  • Electronic development and validation
  • Mechanical
  • Automation
  • Usability and human factor

Industrialisation, Qualification and Validation

  • Equipment qualification
  • Validation of computerised processes and systems
  • Engineering project management
  • Renovation

Regulatory affairs

  • Drafting and updating of technical dossiers (510(k)/EC marking)
  • Version management for ISO 13485
  • Registration/submission for FDA, Europe, China
  • Change control
  • Labelling

Quality

  • System quality
  • Operational quality
  • Product quality

Supply chain and production project management

  • Packaging
  • Serialisation
  • Continuous improvement
  • Lean management
  • Maintenance
  • Logistics
  • Flow management
  • Purchasing
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.

The aim of our interventions is to respond to our clients’ problems as accurately and appropriately as possible.

  • Consulting activity: Individual management of resources | Contract for each consultant | Responsiveness and flexibility | Commitment of resources | Commitment of means
  • Closed projects: Projects based on defined specifications | Project management by Projects Solutions | Implementation of a multi-disciplinary team | Commitment to results
  • Team as a service: Centralised activity | Delegation of management | Single contract | Management of skills and resources by Projects Solutions | Commitment of resources | Commitment of resources
  • Managed services: Management of recurring activities | Division of activities into tasks or work packages | Workload management by Projects Solutions | Commitment of results
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