Local Regulatory Affairs

We specialize in country-level regulatory support and act as the local regulatory affairs 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. Each service can be ordered as stand-alone activity, or as a complete package for a full regulatory affiliate outsourcing.

Services Offered:

Product Life-Cycle Management

Regulatory Intelligence, professional advice and regulatory consulting

Artwork review & management

Regulatory compliance oversight

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

Marketing Authorization Transfer Considerations

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

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Nov 04, 2021

Regulatory Affairs Outsourcing Considerations

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

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Aug 03, 2020

Bringing the Dossiers into Compliance in the EAEU

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