Product Launch Support

We provide regulatory affairs services linked to the product launch activities on country-level across EU/EEA members states. We can help you execute effective medicinal product launch strategies and achieve compliance with EU/EEA and local regulatory requirements. Our thorough understanding of complex regulatory frameworks and national regulatory bodies will help you navigate the route to success.

We can help you plan the launch of your product, advice on the expected timelines, as well as anticipate potential pitfalls and risks that might cause delays. Our expertise will help you achieve optimal success in bringing your product to market and patients.

If you are planning a your product launch in the EU, you may also find our blog article about the EU Medicinal Product Launch Considerations worth reading.

Services Offered:

Consultancy on local regulatory requirements for product launch

Labelling exemptions to supply product in foreign packaging

Educational Materials adaptation to local requirements and approval with national authority

Artwork review and approval, including ‘blue-box’ requirements and additional information

Consultancy on shared pack requirements

Pricing application and local price approval

Reimbursement applications

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Product launches supported across EU
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Promotional materials reviewed per year
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Product aRMM implementations supported

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Jun 08, 2022

Product Launch in the EU: Regulatory Affairs Considerations

The launch of medicinal products in the European Union (EU) is a…

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Apr 22, 2020

Local Person for PV (LPPV) Strategy Considerations

To ensure the safety of their products Marketing Authorization Holders (MAHs) must…

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Jan 11, 2022

Marketing Authorization Transfer Considerations

Overview The high level of Mergers and Acquisitions (M&A) reflects the incredibly…