European
Pharmaceutical
Specialists

Pharmacovigilance & Regulatory Affairs for a safer and healthier tomorrow

Pharmacovigilance &
Regulatory Affairs across Europe

Specialized regulatory and safety support for pharmaceutical companies operating in Spain and across European markets.

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Knowledge
Regulation
Patients
A healthier Europe

Pharmacovigilance

Safety operations and pharmacovigilance systems tailored to your needs.

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Regulatory Affairs

Regulatory strategy and lifecycle management for medicinal products.

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Quality & Compliance

Robust processes, documentation and inspection readiness.

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Expertise across the medicinal product lifecycle

Development
Registration
Authorisation
Post-authorisation
Pharmacovigilance

European expertise. Local understanding.

European Union

Support across EU regulatory procedures and medicinal product lifecycle activities.

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Spain

National regulatory support and local pharmacovigilance requirements.

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Committed to regulatory excellence and patient safety

Because medicines make a difference.

Regulatory intelligence

Latest updates and insights

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EU legislation

Revision of the EU pharmaceutical legislation: key developments

An overview of the main changes and next steps for pharmaceutical companies.

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Pharmacovigilance

EMA updates to the Good Pharmacovigilance Practices (GVP)

Key changes and their impact for MAHs.

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Spain

AEMPS publishes new guidance on safety reporting

Main aspects and practical considerations for marketing authorisation holders.

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