10 — SERVICE
SpecializedIn-CompanyTraining.
Team training in regulatory affairs, compliance and good practices. Customized programs for specific needs.
Learning
Training programs.
Practical training delivered by market specialists.
Regulatory Affairs
Fundamentals and updates in sanitary regulation.
- Regulations and legislation
- ANVISA processes
- Regulatory updates
Good Practices
Training in GMP, GDP, GLP and specific good practices.
- Medicine GMP
- Distributor GDP
- Laboratory good practices
Quality
Training on management systems and quality tools.
- ISO 9001 and 13485
- Quality tools
- Internal audits
Compliance
Training on regulatory compliance and ethics.
- Regulatory compliance
- Code of conduct
- Risk management
Pharmacovigilance
Training on product safety and technovigilance.
- PV fundamentals
- Event notification
- Signal management
Customized
Programs developed tailored to your needs.
- Needs analysis
- Personalized content
- Effectiveness evaluation
How we work
A clear path, from diagnosis to approval.
The same method in every project: understand the product, chart the route and steer the process to a decision — with visibility at every step.
Diagnosis
Deep dive into the product, the operation and the applicable regulatory framework.
Strategy
Route definition: requirements, documentation, deadlines and owners.
Execution
Dossier preparation, filing and dialogue with the regulatory authority.
Approval and maintenance
Follow-through to the decision and post-approval management to keep everything valid.
Train your team
Practical and up-to-date training to elevate your team's technical level.