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Europe

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Southern Africa

Angola - English
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APAC

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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 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

Successful Completion of 4 High Quality CSR Publishing in Short TAT

End-To-End Paper to DIN eCTD Submissions In a Single Day

End-to-End Toxicology Risk Assessment for Perfumes in the European Economic Area

Successful DMF submissions Within One Week With 70% Cost Benefits

Successful Completion of 200 CSRs Within 5 Days

Critical LCM Submissions in a Record Time of A Single Day

Successful NDA Medical Device Submissions Within 16 Days

Zero-Defect Largest NDA Submission Within 5 Days

Successful Submission of 150+ MAs Within 1 Month With 50% Increase in Cost Benefits

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