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.
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Focused solutions.
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.
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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…
Albania
Austria
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Georgia
Germany
Greece
Hungary
Iceland
Ireland
Italy
Kosovo
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Moldova
Montenegro
Netherlands
Northern Macedonia
Norway
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
Armenia
Azerbajan
Bahrain
Bangladesh
Brunei Darussalam
China
Hong Kong
India
Indonesia
Iran
Iraq
Israel
Japan
Jordan
Kazakhstan
Kuwait
Kyrgyzstan
Lebanon
Macao
Malaysia
Mongolia
North Korea
Oman
Pakistan
Palestine
Philippines
Qatar
Saudi Arabia
Singapore
South Korea
Syrian Arab Republic
Taiwan
Tajikistan
Thailand
Turkey
Turkmenistan
UAE
Uzbekistan
Vietnam
Yemen
Australia
New Zealand
Argentina
Aruba
Bolivia
Brazil
Chile
Colombia
Costa Rica
Curaçao
Dominican Republic
Ecuador
El Salvador
Falkland Islands
French Guiana
Guatemala
Guyana
Honduras
Nicaragua
Panama
Paraguay
Peru
Puerto Rico
Suriname
Trinidad & Tobago
Uruguay
Venezuela
Bahamas
Barbados
Belize
Canada
Jamaica
Mexico
USA
Algeria
Botswana
Burkina Faso
Cameroon
Congo
Egypt
Ethiopia
Gabon
Ghana
Guinea
Kenya
Libya
Madagascar
Malawi
Mali
Mauritania
Mauritius
Morocco
Mozambique
Namibia
Nigeria
Rwanda
Senegal
South Africa
Sudan
Swaziland
Tanzania
Togo
Tunisia
Uganda
Zimbabwe
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.