Quality Management
Suppliers and service providers are part of the quality system of anyone operating regulated products. We structure their qualification and audit programme (with quality, health, safety and environmental requirements) and keep the records of each assessment.
- Company stage
- Sustain
The quality programme.
From the requirements set for each partner to ongoing monitoring, with documentation ready for audit.
Requirements per partner
Prerequisites for each supplier or service provider, by segment, product class and contracted service.
- Quality, health, safety and environment
- Criteria by segment
Audits
Document and on-site audits of suppliers, partners and the operation itself.
- Document audit
- On-site audit
- Non-conformity records
Monitoring
A monitoring and control plan for each qualified partner.
- Monitoring plan
- Periodic requalification
Operating procedures
Review and implementation of procedures aligned with the required Good Practices.
- Procedure review
- Implementation and training
Evidence for inspectors
Legal documents and quality programme evidence kept up to date, ready for inspection.
- Reviews and revalidations
- Programme evidence
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Other services for this stage.
- Regulatory ManagementSustainDeadlines, renewals and ancillary obligations for licences and registrations, followed continuously.
- Post-Registration ActivitiesSustainChanges, revalidations, registration certificates and Certificates of Free Sale after approval.
- In-Company TrainingSustainTailored programmes on quality, operational routines and training policy.
Common questions before you start.
What does regulatory quality management include?
The qualification and audit of suppliers and partners against quality, health, safety and environmental requirements, keeping the records of each assessment, and support for the quality system procedures required by Good Practices.
Why qualify suppliers and service providers?
In the distribution, storage and transport of medicines, for example, ANVISA’s guidance is that the contracting company’s quality system assesses each service provider case by case, through its regulatory documents and, whenever possible, an on-site audit. Qualification is the record of that assessment, with defined criteria.
How often is the qualification reviewed?
We treat qualification as a cycle: reassessment follows the supplier’s criticality and performance history, with up-to-date evidence. We set up the calendar and keep the records.
Last updated: October 2026.
Need to qualify suppliers and partners?
We structure the qualification and audit programme for your segment and product class.