Quality strategy
Driving quality strategies and building quality systems in new facilities.
Leadership
Experience that
sets the standard.
Meet the pharmaceutical quality leaders behind Steripharm Solutions.
04
Meet
the team
Founder & PresidentPramod
Sharma, Ph.D.
Sharma, Ph.D.
Founder & president
Pramod Sharma,
Ph.D.
A senior level industry leader, Pramod delivers expertise in quality systems for both clinical and commercial pharmaceutical manufacturing.
He develops quality strategies, establishes systems for new facilities, and improves existing systems for Rx and OTC drug manufacturers, as well as 503B and 503A compounding facilities.
Dr. Sharma’s commercial and clinical manufacturing experience includes sterile injectables; sterile ophthalmic and otic drops, gels, and ointments; non-sterile oral dosage forms; and sterile and non-sterile transdermal and transmucosal dosage forms.
Expertise
A quality perspective shaped
by the whole product journey.
Optimizing existing systems at drug manufacturing firms and 503B and 503A compounding pharmacies.
Global partnerships
Managing projects and partnerships with CMOs in the Americas, Europe, and India.
Professional experience
A career in quality.
Leadership experience spanning consulting, pharmaceutical quality, and microbiology.
Steripharm Solutions
Consulting services
ImprimisRx, Harrow Health Inc.
Vice President, Quality
Alvogen
Senior Director, Quality
Albany Molecular Research, Inc. (AMRI)
Senior Director, Quality
Akorn, Inc.
Executive Director, Global Quality Compliance
Director, Quality · Manager, Quality · Manager, MicrobiologyLabCorp
Director, Microbiology and Serology
Education & research
Scientific depth,
business fluency.
Rigorous scientific training and business education inform a pragmatic perspective on quality.
Certificate in Business Excellence
Columbia Business School, New York
Ph.D. Microbiology
University of Oklahoma, Oklahoma
M.S. Biotechnology
AMU, Institute of Biotechnology, India
B.S. Biology
Punjab University, DAV College, India
Postdoctoral research
Stanford University, California
Brookhaven National Laboratory, New York
Featured associate
Madan
Chilakuri
A regulatory affairs professional with a background in NDA 505(b)(2) and ANDA submissions.
Madan has facilitated successful ANDA submissions and participated in successful Pre-IND meetings of 505(b)(2) NDAs for injectables and liquid oral dosage forms. He has obtained waiver for clinical studies requirement for NDAs.
His expertise includes FDA communications; Drug and Device Establishment Registrations; FDA deficiency responses; and eCTD compilation and submission of ANDA, NDA, and DMF filings. He is a board-certified pharmacist in Wisconsin with an M.S. degree in Chemistry and B.S. in Pharmacy.
Start with clarity
Build sustainable compliance into every next step.
Talk with Steripharm Solutions about your quality, compliance, and manufacturing objectives.