An expert balancing act across many areas.
Regulatory strategy is a sensitive mix of fulfilling current global and local legislation requirements, meeting committed timelines, and keeping the balance between stakeholders.
It integrates and interconnects regulatory objectives, internal and external factors, key milestones and decision points, risks foresight, mitigation and minimization, regulatory precedents- everything to launch and successfully maintain a product on the market.
Considering that regulatory strategy encompasses both science-driven, legal assessment and business purposes, a truly cross-functional team is required to handle the intricacies involved.
Through their extensive knowledge and understanding of applicable legislation, therapeutic areas, product types, and the country or regions involved, our expert team can meet all your regulatory strategy objectives, with sustainable competitive advantages.
By truly understanding your needs we can make decisions based on individualized target product profiles, making the best use of new regulatory tools to proactively identify challenges and uncover key opportunities.
Arriello holds an SME status which means we can offer an alternative process by acting as the applicant for a submission. How can that help you?
- We receive incentives as an SME resulting in smaller fees for our clients.
- We act within the EEA.
Ultimately we can act as an extension of your organization, making the whole process easy, efficient and pain free.
Selected Regulatory Affairs Case Studies.View all
What our clients say about us.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.