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South America

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Brazil - English
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Ecuador - English
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Guatemala - English
Guyana - English
Panama - English
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Peru - English
Puerto Rico - English
Suriname - English
Uruguay - English
Venezuela - English

East Europe

Kazakhstan - English
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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
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Denmark - English
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Finland - English
France - English
Georgia - English
Germany - German
Greece - English
Hungary - English
Iceland - English
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Latvia - English
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Luxembourg - English
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Malta - English
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Netherlands - English
Norway - English
Poland - English
Portugal - English
Romania - English
San Marino - English
Slovakia - English
Slovenia - English
Spain - English
Sweden - English
Switzerland - English
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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
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Ghana - English
Guinea - English
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Iraq - English
Israel - English
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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

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Medical Devices Expertise

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Services Type

Cosmetics Expertise

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Food and Food Supplements Expertise

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Services Type

Case Studies

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

Product Registration and Variation Submissions to 12 African Countries

Zero-error Europe MAA Submission in eCTD Format

Error-free Major Variation Submissions in eCTD format to Australia

Successful DIN Submissions in eCTD format to Health Canada

Successful Baseline Paper to eCTD submissions to GCC Oman

Successful Regulatory Support For DMF, ANDA Pre- and Post- Approval Activities

DMF CTD Conversion and eCTD Publishing for Type II and IV DMFs

End-to-End Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions

Successful NDA - Medical Device Submission in Reduced Delivery Time frame (from 50 days to 16 Days)

70 Submissions in 3 Months with Zero-Defects

345, 177 and 198 Successful Submissions for ROW, Europe and the USA Respectively Within 3 Months

Successful IND Submission in 4 Weeks with 70% Compliance Cost Savings

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