Licensed expertise for regulated markets
In many European countries, local market access requires an authorized exploitant. These operators hold a specific license and must be accountable for pharmacovigilance, batch control, quality oversight, product information, and distribution compliance. At Cencora, we provide regulated exploitant services through trusted local partners. By partnering with us, you will gain the confidence that your products launch with the appropriate legal authority and compliance, from labeling and safety monitoring to distribution.
What’s included in our service:
- Licensed exploitant status: Oversight through an authorized local partner who holds national marketing and distribution responsibility.
- Regulatory compliance: Batch tracking, artwork review, packaging control, product complaint handling, and recall management.
- Pharmacovigilance and medical information: Local adverse event management and 24/7 support for healthcare professionals and patients.
- Quality monitoring and partner audits: Helping to ensure robust supply integrity and proactive prevention of supply issues.
- Advertising oversight: Review and approval of promotional content and medical rep activity.
- GDP-aligned storage and distribution: Medicine handling per local standards, with batch follow-up and mock recall readiness.
Here’s how our exploitant services support compliant, confident product launches:
Reverse logistics isn’t just about moving products back — it’s a critical part of a more agile, informed supply chain.
Single-point coordination
Pharmacovigilance
Reliability
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If you're preparing a European market launch in a country that requires exploitant oversight, our team can guide you through qualification, batch release, pharmacovigilance setup, and distribution coordination.