Regulatory Affairs overview

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 our Regulatory Affairs services brochure…

We’ve the depth and expertise to help you with any project.

Gabriela Marton, Arriello’s Regulatory Affairs Director, gives an overview of the services that we provide for our clients in regulatory, from development to lifecycle management.

She also talks about our Regulatory team’s strengths, experience, and the challenges which we can help you overcome, faster, better, smarter.

I'm proud to lead an experienced, passionate and enthusiastic team at Arriello. We are focused on providing quick, effective and strategic regulatory solutions for our clients, guiding them through implementation, or acting as their extended regulatory team.

Global Pharmaceutical Regulatory Affairs Gabi
Gabriela Marton
Regulatory Affairs Director
Ready to contact us?

Webinar.

Biosimilars in Europe: Pricing, Interchangeability and Policy.

Gabriela Marton, Arriello`s Regulatory Director discusses the current landscape and outlook for the European biosimilars market in this highly rated Xtalks webinar recording.

As also shared at this year’s 2020 RAPS #EuroConvergence conference.

I'm proud to lead an experienced, passionate and enthusiastic team at Arriello. We are focused on providing quick, effective and strategic regulatory solutions for our clients, guiding them through implementation, or acting as their extended regulatory team.

Vlog archive

Where our Regulatory services start in a typical product life cycle.

Faster, better, smarter, Regulatory Affairs.

Delivering on our faster, better, smarter promise means really understanding our clients’ requirements and where they want to be strategically over all stages of their products’ life cycles.

Anna Lukyanova, Arriello’s COO talks about how that approach impacts the bottom line, day to day, for our clients.

We cannot leave any room for questions or assumptions. We always explain to our clients and regulatory authorities what we plan to do and what we have done. And we always try to improve on our communication, because it is an element that clients really feel and appreciate, and that makes us better every day.

Video: Faster, better, smarter Pharmacovigilance.
Anna Lukyanova
COO

Click an area to see the countries where we operate…

European and Russian coverage
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
Asia
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
Oceania / Pacific
Australia
New Zealand
South America
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
North America
Bahamas
Barbados
Belize
Canada
Jamaica
Mexico
USA
Africa
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
European and Russian coverage

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

Asia

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

Oceania / Pacific

Australia
New Zealand

South America

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

North America

Bahamas
Barbados
Belize
Canada
Jamaica
Mexico
USA

Africa

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.

Bluefish Pharmaceuticals, India

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.

View all