Sid Mathur Email & Phone Number | Regulatory Affairs professional with extensive demonstrated experience in the devolopment of In-Vitro Diagnostic (IVD) Medical Devices, especially Companion Diagnostics (CDx). Deep understanding of pharmaceutical and diagnostic regulations as well as multi-discplinary (e.g. techinical, statistical and clinical) concepts pertaining to CDx development obtained through working in/with leading diagnostic and pharmaceutical companies. Have strong expertise in US regulations across the IVD development spectrum - from leading/participating in pre-submissions to FDA (CDRH, CDER), helping with study starts (NSR determinations, IDE submissions) to supporting PMA/sPMA (and drug) applications. Have provided regulatory input to CDx projects spanning multiple biomarkers (e.g. PD-L1, MSI, MMR, TMB, HRD, BRCA) and technologies (IHC, PCR, NGS). Strong direct and indirect ex-US CDx regulatory experience (e.g. China, Japan, EU, Australia, S. Korea).

Sid Mathur

Regulatory Affairs professional with extensive demonstrated experience in the devolopment of In-Vitr...
Harleysville, Pennsylvania, United States

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Sid Mathur’s Email sid.mathur@merck.com

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Sid Mathur’s Location Harleysville, Pennsylvania, United States

Sid Mathur’s Current Industry Merck

Sid Mathur’s Prior Industry Roche Tissue Diagnostics | Focus Diagnostics | Mdi Consultants

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Regulatory Affairs Executive Director, Companion Diagnostics

2021-06-01T00:00:00.000Z - Present

Senior Manager Regulatory Affairs

2013-09-01T00:00:00.000Z - 2014-06-01T00:00:00.000Z

Regulatory Affairs Specialist

2007-03-01T00:00:00.000Z - 2011-06-01T00:00:00.000Z

Consultant

2005-07-01T00:00:00.000Z - 2007-03-01T00:00:00.000Z

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Sid Mathur is a Regulatory Affairs professional with extensive demonstrated experience in the devolopment of In-Vitro Diagnostic (IVD) Medical Devices, especially Companion Diagnostics (CDx). Deep understanding of pharmaceutical and diagnostic regulations as well as multi-discplinary (e.g. techinical, statistical and clinical) concepts pertaining to CDx development obtained through working in/with leading diagnostic and pharmaceutical companies. Have strong expertise in US regulations across the IVD development spectrum - from leading/participating in pre-submissions to FDA (CDRH, CDER), helping with study starts (NSR determinations, IDE submissions) to supporting PMA/sPMA (and drug) applications. Have provided regulatory input to CDx projects spanning multiple biomarkers (e.g. PD-L1, MSI, MMR, TMB, HRD, BRCA) and technologies (IHC, PCR, NGS). Strong direct and indirect ex-US CDx regulatory experience (e.g. China, Japan, EU, Australia, S. Korea).