LEADERSHIP

MEET OUR FOUNDER & PRESIDENT
PRAMOD SHARMA

Pramod Sharma, Ph.D., a senior level industry leader, delivers expertise in the development and manufacture of pharmaceutical Rx and OTC products globally. He is skilled at driving quality strategies, setting up quality systems in new facilities, and optimizing existing systems at drug manufacturing firms and compounding pharmacies. Dr. Sharma’s commercial and clinical manufacturing experience includes a) sterile injectables, b) sterile ophthalmic and otic drops, gels, and ointments, c) non-sterile oral (solid and liquid) dosage forms, and d) sterile and non-sterile transdermal and transmucosal dosage forms. He has managed projects and partnerships with Contract Manufacturing Organizations (CMOs) in the Americas, Europe, & India.

PROFESSIONAL EXPERIENCE

Consulting services

ImprimisRx, Harrow Health Inc.
- Vice President, Quality

Alvogen
- Senior Director, R&D Quality

Albany Molecular Research, Inc. (AMRI)
- Senior Director, Quality

Akorn, Inc.
- Executive Director, Global Quality Compliance
- Director, Quality
- Manager, Quality
- Manager, Microbiology

LabCorp
- Director, Microbiology and Serology

EDUCATION

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

OUR FEATURED ASSOCIATES
MADAN CHILAKURI

Madan Chilakuri is a regulatory affairs professional with a background in NDA 505(b)(2) and ANDA submissions. Madan has facilitated many successful submissions of ANDAs. He has also 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. Madan has a clear understanding of regulatory requirements for NDA and ANDAs.

Madan is the US Agent for multiple organizations for FDA communications and Drug/Device Establishment Registrations. He has extensive experience in preparing responses for FDA deficiencies. He has expertise in eCTD compilation and submission of ANDA, NDA and DMF filings to FDA. Madan is a board-certified pharmacist in Wisconsin and has a M.S. degree in Chemistry and B.S. in Pharmacy.