Regulatory Affairs Archieven

Local Affiliate Services That Deliver the Best Results

by Anna Kamocsai | Aug 13, 2025 | Regulatory Affairs

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

by Anna Kamocsai | Aug 8, 2025 | Regulatory Affairs

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

by Anna Kamocsai | Aug 8, 2025 | Regulatory Affairs

Struggling with outdated dossiers and complex regulatory requirements?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.

by Anna Kamocsai | Jul 21, 2025 | 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...

Regulatory Outsourcing in the CEE Region

by Anna Kamocsai | Jul 21, 2025 | Regulatory Affairs

In this informative session we decode the intricate landscape of regulatory affairs outsourcing in the CEE region and provide practical, implementable strategies to optimize and maximize your operations and outsourcing strategies. Optimizing your regulatory operations...

Regulatory Framework of Drugs in MENA: Insights

by Anna Kamocsai | Jul 21, 2025 | Regulatory Affairs

In this webinar, our experts discuss regulatory affairs of medicinal products. Two aspects that have recently gained increasing importance among the various stakeholders, namely the eCTD implementation across the region and the serialization and barcoding requirements...

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Local Affiliate Services That Deliver the Best Results

Harmonizing Product Information Across Baltic Markets

Dossier Transformation for Market Expansion

Affiliate Based Outsourcing Model for Regulatory Affairs.

Regulatory Outsourcing in the CEE Region

Regulatory Framework of Drugs in MENA: Insights

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Local Affiliate Services That Deliver the Best Results

Harmonizing Product Information Across Baltic Markets

Dossier Transformation for Market Expansion

Affiliate Based Outsourcing Model for Regulatory Affairs.

Regulatory Outsourcing in the CEE Region

Regulatory Framework of Drugs in MENA: Insights

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