Local Regulatory Affairs

We specialize in country-level regulatory support and act as the local regulatory unit for pharmaceutical company corporate teams and affiliates across countries in the EEA/EU, CIS, and MENA regions.

Our local regulatory affairs services span through the complete product life cycle and help customers achieve maximum local compliance while marketing their medicinal products. We provide regulatory affairs support from pre-submission services up to complete post-approval regulatory maintenance.

Services Offered:

Product Life-Cycle Management

Regulatory Intelligence, professional advice and regulatory consulting

Promotional Materials review and approval

Artwork review & management

Regulatory compliance oversight

New MAA & Procuct Approval support

Product Launch support

Product/Portfolio Acquisitions support (e.g. Dossier Gap-Analysis, MA transfers)

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Marketing Authorization Transfers supported
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Promotional materials reviewed per year
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aRMM approvals supported

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Jan 11, 2022

Fundamental Challenges During a Marketing Authorization Transfer Process in EU

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

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Nov 04, 2021

Regulatory Affairs Outsourcing: Benefits, Tasks and Future Perspectives

The pharmaceutical market is rapidly evolving and changing. Many pharmaceutical companies are…

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Aug 03, 2020

Bringing the Dossiers into Compliance with the EAEU Requirements

Until December 31, 2025, the Eurasian Economic Union (EAEU) which consists of…