Regulatory Affairs, Operations, Intelligence, Case Studies

North America

Canada - English
USA - English
Mexico - English

South America

Argentina - English
Bolivia - English
Brazil - English
Chile - English
Colombia - English
Costa Rica - English
Dominican Republic - English
Ecuador - English
French Guiana - English
Guatemala - English
Guyana - English
Panama - English
Paraguay - English
Peru - English
Puerto Rico - English
Suriname - English
Uruguay - English
Venezuela - English

East Europe

Kazakhstan - English
Kosovo - English
Kyrgyzstan - English
Serbia - English
Tajikistan - English
Turkmenistan - English
Ukraine - English
Uzbekistan - English

Europe

Albania - English
Andorra - English
Armenia - English
Austria - English
Belarus - English
Belgium - English
Bosnia & Herzegovina - English
Bulgaria - English
Croatia - English
Cyprus - English
Czech Republic - English
Denmark - English
Estonia - English
Finland - English
France - English
Georgia - English
Germany - German
Greece - English
Hungary - English
Iceland - English
Ireland - English
Italy - English
Latvia - English
Liechtenstein - English
Lithuania - English
Luxembourg - English
Macedonia - English
Malta - English
Moldova - English
Monaco - English
Montenegro - English
Netherlands - English
Norway - English
Poland - English
Portugal - English
Romania - English
San Marino - English
Slovakia - English
Slovenia - English
Spain - English
Sweden - English
Switzerland - English
United Kingdom - English
Vatican City - English

North Africa & Middle East

Algeria - English
Bahrain - English
Benin - English
Burkina Faso - English
Burundi - English
Cameroon - English
Central African Republic - English
Chad - English
Djibouti - English
Egypt - English
Eritrea - English
Ethiopia - English
Gabon - English
Gambia - English
Ghana - English
Guinea - English
Guinea Bissau - English
Iraq - English
Israel - English
Ivory Coast - English
Jordan - English
Kenya - English
Kuwait - English
Lebanon - English
Liberia - English
Libya - English
Mali - English
Mauritania - English
Morocco - English
Niger - English
Nigeria - English
Oman - English
Palestine - English
Qatar - English
Rwanda - English
Saudi - English
Senegal - English
Sierra Leone - English
Syria - English
Togo - English
Tunisia - English
Turkey - English
United Arab Emirates - English
Uganda - English
Yemen - English

Southern Africa

Angola - English
Botswana - English
Democratic Republic of the Congo - English
Lesotho - English
Madagascar - English
Mauritius - English
Malawi - English
Mozambique - English
Namibia - English
Seychelles - English
South Africa - English
Swaziland - English
Tanzania - English
Zambia - English
Zimbabwe - English

APAC

Bangladesh - English
Bhutan - English
Brunei - English
Cambodia - English
China - English
Fiji - English
Hong Kong - English
India - English
Indonesia - English
Laos - English
Malaysia - English
Maldives - English
Mongolia - English
Myanmar - English
Nepal - English
Pakistan - English
Philippines - English
Russia - English
Singapore - English
Sri Lanka - English
Taiwan - English
Thailand - English
Timor Leste - English
Vietnam - English

Australia & New Zealand

Australia - English
New Zealand - English

Japan & South Korea

Japan - English
South Korea - English

Pharmaceuticals Expertise

Our Presence

Medical Devices Expertise

Our Presence

Services Type

Cosmetics Expertise

Our Presence

Nutraceuticals / Food Supplements Expertise

Our Presence

Services Type

Case Studies

End-to-End Implementation of A Validated Document Management System (DMS) for Labeling on OpenText^™

Successful Regulatory Artwork Support During M&A Within 3 Months

24x7 Artwork Creation, Proofreading, And QC Services

Comprehensive Regulatory Artwork Support with 99.99% Quality Deliverables

RI Report on Digital Clinical Trial Data Capture System in the US and EU

Successful Regulatory Support for A Technical Change with COFEPRIS

Successful 50+ SPL Submissions In 20 Days

Successful Regulatory Support for SPL submissions within two weeks

Successful ANDA Filing with zero deficiency

Successful DMF Filings in the USA and Canada

100% Accurate Submissions to USFDA

ANDA and PADER Submissions with Zero Deficiency

Successful Type III DMF Compilation and eCTD Submission to USFDA

Timely Compilation and Submission of Annual Report for NPH Otic to the USFDA

Timely Compilation and Submission of Annual Report for NPH Opth to the USFDA

Successful Medicinal Product Registration in Indonesia

24x7 Artwork Creation and Proofing Services in India

Regulatory Intelligence on PPO Policies in India

Medical Device Classification Support in India (As Per CDSCO)

Device Classification, Regulatory Approach Identification and Registration Services in Mexico

Successful BLA Submissions with Zero Deficiencies for US Region

Pages

Have a business query? Let’s talk.

Quick Inquiry

Freyr’s Global Presence