Regulatory Affairs
- Integral advisory of product registration strategies.
- Dossier development, presentation and follow up of approval requests before the different Health authorities, in both National and Provincial level.
- Consultation services for business inscriptions at National and Provincial level.
- National and provincial habilitations.
Technical services
- Design/modification of productive areas
- Current lay out optimization.
- Validation of areas, equipments and processes.
- Technical and administrative files management.
Quality Management
- Development and implementation of Quality Management Systems (SGC), according to GMP and ISO 9001:2008.
- Consultancy for internal audits (self-inspections) and external audits (suppliers).
- Drafting of Standardized Operative Procedures (SOPs).
- Quality manuals development.
Trainings
- In-company courses: custom-made according to the Client needs, about several subjects:
Application and comprehension of GMP
Quality: as a concept and how to achieve it.