agap2 Sweden is a consulting and engineering company specilised in the pharma, biotech medtech sectors.
Discover our areas of expertises.
Research & Development
- Analytical method development
- Upstream & Downstream
- Formulation
- Bioprocess development
Quality
- Quality assurance
- Quality control
- Regulatory affairs
Quality Control
In quality control, our consultants carry out visual inspections, investigations, analysis of incoming materials and finished products to ensure the quality of medical devices and biologics.
Quality Assurance
Our consultants work on batch documentation review, deviation investigations, CAPA and change control for sterile manufacturing and solid preparations as well as for the quality control department. In another assignment, our consultant works on validation work of a production update and the sterile manufacturing.
Project management
- Project management R&D or Engineering
- Cost control
- Planning
- Risk management
Our consultant works as an interim manager and project manager within the quality department coordinating the team and the ongoing projects in quality management.
Process and Validation
- Process engineering
- Qualification & Validation (equipments & systems)
- Cleaning validation
- Automation engineering
- Lean Manufacturing
Our process engineers work on optimizing production processes and have cross-functional roles handling various process engineering issues, investigations, deviations and tech transfer at various pharmaceutical and biotech companies.
Production
- Supply Chain management
- Purchasing
- Lean Manufacturing
- Logistic
1 - Bioprocess analytical development for Galderma.
Our consultant works on product development where he performs various analyses using protein-based methods, calibrates equipment and develops methods.
2 - Bioprocess development for GE Healthcare.
Our consultant is part of the research and development department where he prepares and evaluates DNA. The consultant works with mammalian cell cultures and generates material for further studies.
3 - Process validation for Recipharm.
Our consultant is working on validation of manuals for two new products, also with production ramp-up, risk assessments, SOP validations and training staff.
4 - Quality Control for Merck.
A team of consultants has supported Merck with QC laboratory development, from establishing laboratory equipment specifications and procurement follow-up, to qualification and updating of SOPs.
5 - Regulatory Affairs for Abbott.
Our consultant works on regulatory issues, prepares documentation for launch of a new product on the market.
Different levels of commitment.
Our intervention methods are designed to offer services at different levels of commitment.
- Results-based engagement
The results commitment is adapted to services for which the client wants agap2 to commit to the achievement of fixed objectives. It is intended for projects defined in the specifications, for which agap2 proposes a costing per task or project milestone. It allows the search for optimisation and productivity gains and is distinguished by invoicing by deliverables (tasks or milestones).
- Commitment of resources
The commitment of resources 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 invoicing for time spent on the project.
Discover our working methods.
Our interventions aim to respond to our clients’ problems in the most accurate and appropriate way possible.
- Consulting activity: Individual management of resources | Contract for each consultant | Responsiveness and flexibility | Commitment of means
- Defined projects: Projects based on defined specifications | Project management by Projects Solutions | Implementation of a multidisciplinary team | Commitment to results
- Technical platform: Centralised activity | Delegation of management Single contract | Management of skills and resources by Projects Solutions
| Commitment of means - Outsourcing: Management of recurrent activities | Division of activities into tasks or work packages | Management of the workload by Solutions Projects | Commitment to results
