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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

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