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.
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)