Local Affiliate Services That Deliver the Best Results
Local affiliate services are vital for pharma and biotech companies entering new markets, especially in regions like CEE, CIS, and MENA where regulatory requirements differ from centralized norms. These affiliates act as in-country regulatory partners, liaising with...
Harmonizing Product Information Across Baltic Markets
Navigating multilingual product information across several markets can be complex – but it doesn’t have to be. In this case study, we share how one of our partner companies successfully harmonized their SmPC, PIL, and labelling across the Baltic region, working with...
Dossier Transformation for Market Expansion
Struggling with outdated dossiers and complex regulatory requirements? We partnered with a large pharma company to transform a fragmented legacy submission into a fully CTD-compliant dossier for successful market expansion in Europe. In this case study, we break down...
Affiliate Based Outsourcing Model for Regulatory Affairs.
Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources. Many challenges come up from managing your RA activities as sometimes their processes are not harmonized across different...
