Regulatory Affairs Overview.
Knowing how, when, and where.
A smarter approach to Pharmaceutical Regulatory Affairs.
The decisions you make about your regulatory strategy can fuel your growth, or create unnecessary obstacles.
Successfully navigating regulatory requirements is more than simply following the rules, it is about understanding the complexities and implications of different procedures and requirements across world markets and linking regulatory intelligence and experience with your needs.
And we have the in-house expertise to develop and execute the right strategy worldwide across the EU, North America, LATAM, MENA, CIS, APAC regions and South Africa.
We can also support your internal regulatory and market access teams by supplementing any missing capacity or capability with a fast, agile, and tailored service.
Whether you’re a US-based biotech looking to reach specific or all markets, or you’re a more established European company needing guidance, our consultants can advise, plan, and deliver a faster, better, smarter strategy to ensure your products are available to patients around the world.Download full PDF to read more
Designed to support a pan-EU/US development strategy.
Services from early preclinical development to marketing authorization and product lifecycle management.
- QA/QMS development.
- Global PV strategies.
- Regulatory roadmaps & strategies.
- RA/PV/QA due-diligence.
- Target Product Profiles.
- SME designation.
- Early FDA/EMA/UK engagements.
- Orphan & pediatric strategies.
Arriello experts in Europe and the US work within a project team to provide coherent regulatory strategies and operational support.
We offer tailored and optimized services, leveraging the right solution, either in the US, Europe or combined.Download full PDF to read more
Regulatory life cycle timeline. Services by stage and for all stages.
In this video, Arriello’s Chief Regulatory Officer Peter Embley talks about how Arriello is positioned to offer a truly integrated service for biotech and pharma.
The increase in accelerated regulatory development pathways for personalized and rare disease therapies demands a coherent; Regulatory, Pharmacovigilance and QA service offering, at a very early stage. Accelerated regulatory pathways trigger an earlier and more intensive engagement with Reg assessors.
We recognize this, and have a strong commitment to fulfilling these combined needs with an optimized cross-discipline service from the earliest point of need.
Click an area to see the countries where we operate…
Bosnia and Herzegovina
Syrian Arab Republic
Trinidad & Tobago
What our clients say about us.
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
After evaluating several vendors to help us set up and manage our global literature screening process, we chose Arriello due to their professionalism and thorough understanding of global requirements.
Arriello has been truly committed to meeting our needs and providing us with guidance and recommendations along every step of way. We have now been using Arriello for approximately five years and are extremely satisfied with our choice.
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.