Unlock the New EU Variations Guideline with Expert Consultancy

The new EU Variations Guideline came into effect on January 15th, 2026.

At ASPHALION, we’re here to help you navigate these changes with specialized training and consultancy services designed to meet your needs.

Benefit from training led by experts with over 40 years of experience

Insights from pharmaceutical and AEMPS expertise

Pragmatic and tailored approach to client’s business's unique challenges

Expert Consultancy Services for the New Variations Guideline

With the new EU Variations Guideline now applicable, pharmaceutical companies face new regulatory challenges across Europe.

To support a smooth transition, ASPHALION offers dedicated consultancy and training packs designed to help you understand, implement, and confidently manage post-authorisation changes under the new framework.

1.5-hour intensive session Q&A
4 hours of dedicated, personalized follow-up consultancy

3 hours session covering the updated guideline with practical case studies
1 additional hour of personalized ad-hoc consultancy for your specific needs

Variations strategy definition (including annual update, grouping, Worksharing)
Variation preparation and submission
Stakeholder consultation
Life-Cycle Management
CMC
Publishing & Submission

Comparative Variations Guidelines 2013 → 2025

At Asphalion, we are committed to delivering practical and innovative solutions to support regulatory professionals in their daily work.

That’s why we have developed a free-to-use application designed to help you easily compare guidelines in a clear, practical, and user-friendly way.

Our tool allows you to quickly identify key differences, align requirements, and streamline your regulatory strategy — saving time and enhancing decision-making.

Access the application now and start exploring the differences in just a few clicks:

Meet our reference expert:

Ana Viñas is a highly respected expert in quality and regulatory affairs, with more than 40 years of experience gained through a distinguished career in both the pharmaceutical industry and at the Spanish Agency for Medicines and Medical Devices (AEMPS).

She is widely recognized for her in-depth knowledge of regulatory procedures, variations management, quality systems, and regulatory telematics, and is considered a leading authority in these areas.

“We are proud to bring the expertise of Ana, with over 40 years in quality and regulatory affairs across the pharmaceutical industry and AEMPS, to support clients in navigating the new EU Variations Guideline through tailored consultancy and expert-led training.”

Watch Our Webinar!

With the Variations Guideline in effect, this webinar will guide you through the key aspects of practical implementation.

Join Ana Viñas as she shares expert insights, tips, and recommendations to help you navigate the new framework with confidence.

Get expert guidance on the new EU Variations Guideline!

Contact us to learn how our consultancy and tailored training can support your business.

Why Asphalion?

ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages

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ASPHALION’s experts have delivered solutions to over 1,500 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 10,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.