How, when and where.
The smarter approach to Pharmaceutical Regulatory Affairs.
The decisions you make about pharmaceutical Regulatory Affairs can fuel your growth...or create unnecessary obstacles between you and your objectives.
Initially launching your drug in one country can speed up its launch in another, but it might potentially cap your pricing in other countries, or across an entire regulated market! That means successfully navigating regulatory requirements is more than simply following the rules...it’s about understanding the complexities and implications of Decentralised, Centralised and National Procedures, and developing the best strategy around them.
With over 55 years combined experience, Arriello has the in-house expertise to develop and execute that strategy worldwide across the EU, LATAM, MENA, CIS, and APAC regions.
It doesn’t matter if you’re a US-based biotech looking to reach specific or all markets, or you need guidance for OTC authorization. From preparing and maintaining dossiers to providing translation services, we make sure our clients can achieve their goals faster, better, smarter.