Steripharm Solutions LLC is a U.S.-based FDA compliance and pharmaceutical quality assurance consulting firm founded by Pramod Sharma, Ph.D. — a senior-level industry leader whose quality systems expertise spans both clinical and commercial pharmaceutical manufacturing. Manufacturers working with sterile injectables, ophthalmic/otic products, oral dosage forms, and transdermal and transmucosal products turn to the firm specifically because its guidance comes from direct, hands-on leadership experience at major pharmaceutical and compounding organizations, not generic regulatory advice.
This page explains who’s behind Steripharm Solutions, the career and education behind the firm’s approach, and how manufacturers can start working with the team. If you’re evaluating consulting partners for FDA compliance, CGMP remediation, or quality system support, this is the experience behind the guidance you’ve seen across our other resources.
Who Founded Steripharm Solutions?
Steripharm Solutions LLC was founded by Pramod Sharma, Ph.D., a senior-level industry leader who 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.
Connect with Pramod Sharma on LinkedIn → https://www.linkedin.com/company/steripharm-solutions-llc
Takeaway: Pramod Sharma, Ph.D. founded Steripharm Solutions on direct experience building and improving quality systems across the full range of sterile and non-sterile dosage forms, including Rx, OTC, and 503A/503B compounding operations.
What Makes Steripharm Solutions Different?
Steripharm Solutions is built around a quality perspective shaped by the whole product journey — from building a new facility’s quality system from scratch to optimizing an established one, across both pharmaceutical manufacturers and compounding pharmacies. That range, paired with direct global project experience, is what separates the firm’s guidance from generic CGMP consulting.
Three areas of expertise
- Quality strategy — driving quality strategies and building quality systems in new facilities.
- System optimization — 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.
Takeaway: The firm’s differentiation is range — new-facility quality strategy, existing-system optimization, and global CMO partnership management — built on a career that has moved through each of these roles directly, not just advised on them.
A Career in Quality
Dr. Sharma’s leadership experience spans consulting, pharmaceutical quality, and microbiology, built across senior quality roles at some of the industry’s established pharmaceutical and compounding organizations before founding Steripharm Solutions.
Professional experience
| Organization | Role |
|---|---|
| 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, Microbiology |
| LabCorp | Director, Microbiology and Serology |
Takeaway: Dr. Sharma’s path through LabCorp, Akorn, AMRI, Alvogen, and ImprimisRx/Harrow Health before founding Steripharm Solutions reflects progressively senior quality leadership across microbiology, pharmaceutical manufacturing, and specialty compounding.
Education & Research
Rigorous scientific training and business education inform a pragmatic perspective on quality at Steripharm Solutions.
- 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
Takeaway: A Ph.D. in microbiology, postdoctoral research at Stanford and Brookhaven National Laboratory, and a Columbia Business School certificate combine scientific depth with business fluency — the foundation behind Steripharm Solutions’ pragmatic approach to quality.
Featured Associate: Madan Chilakuri
Madan Chilakuri is a regulatory affairs professional with a background in NDA 505(b)(2) and ANDA submissions. He has facilitated successful ANDA submissions and participated in successful Pre-IND meetings of 505(b)(2) NDAs for injectables and liquid oral dosage forms, and has obtained waivers for clinical studies requirements 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. in Chemistry and a B.S. in Pharmacy.
Takeaway: Madan Chilakuri extends Steripharm Solutions’ bench into regulatory submissions — ANDA, NDA, and DMF filings — complementing Dr. Sharma’s quality systems expertise with direct FDA submission experience.
How Do I Start Working with Steripharm Solutions?
Working with Steripharm Solutions starts with a conversation about your quality, compliance, and manufacturing objectives — whether that’s building a quality system for a new facility, optimizing an existing one, managing a CMO partnership, or navigating an FDA finding. From there, the team scopes an approach based on your specific dosage form and situation.
Takeaway: The first step is a conversation about your specific quality and compliance objectives — scope follows from that, not a generic service package.
Frequently Asked Questions
Steripharm Solutions LLC was founded by Pramod Sharma, Ph.D., a senior-level industry leader in pharmaceutical quality systems. His prior roles include Vice President, Quality at ImprimisRx (Harrow Health, Inc.), Senior Director, Quality at Alvogen and at Albany Molecular Research, Inc. (AMRI), and Executive Director, Global Quality Compliance at Akorn, Inc.
Steripharm Solutions serves Rx and OTC drug manufacturers as well as 503B and 503A compounding facilities, with experience across 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.
Engagements start with a conversation about your quality, compliance, and manufacturing objectives, after which the team scopes an approach based on your specific dosage form and facility situation. Reach out through the contact page to begin.
The firm’s expertise spans the full product journey — quality strategy for new facilities, optimization of existing systems, and global partnerships with CMOs across the Americas, Europe, and India. This range comes from Dr. Sharma’s direct career experience across pharmaceutical manufacturing, specialty compounding, and microbiology.
Pramod Sharma, Ph.D. is the founder and president of Steripharm Solutions LLC, with prior senior quality leadership roles at ImprimisRx (Harrow Health), Alvogen, Albany Molecular Research, Inc. (AMRI), Akorn, Inc., and LabCorp. He holds a Ph.D. in Microbiology from the University of Oklahoma, a Certificate in Business Excellence from Columbia Business School, and completed postdoctoral research at Stanford University and Brookhaven National Laboratory.
Dr. Sharma holds a Ph.D. in Microbiology from the University of Oklahoma, an M.S. in Biotechnology from AMU’s Institute of Biotechnology in India, and a B.S. in Biology from Punjab University, DAV College, India. He also completed a Certificate in Business Excellence at Columbia Business School and postdoctoral research at Stanford University and Brookhaven National Laboratory.
Yes, the firm’s expertise specifically includes 503B and 503A compounding facilities alongside traditional Rx and OTC drug manufacturers. This reflects Dr. Sharma’s direct experience, including his role as Vice President, Quality at ImprimisRx, a 503B outsourcing facility under Harrow Health, Inc.
Yes, the firm manages projects and partnerships with CMOs in the Americas, Europe, and India, in addition to its U.S.-based FDA compliance focus. This global partnership experience is one of the firm’s three core areas of expertise.
Madan Chilakuri is a featured associate at Steripharm Solutions specializing in regulatory affairs, with a background in NDA 505(b)(2) and ANDA submissions, FDA communications, and eCTD filings. He is a board-certified pharmacist in Wisconsin with an M.S. in Chemistry and a B.S. in Pharmacy.
You can reach the Steripharm Solutions team through the contact page to talk about your quality, compliance, and manufacturing objectives.
Conclusion
Steripharm Solutions LLC exists because manufacturers need compliance guidance grounded in real, senior-level quality leadership — not generic regulatory language. Founded by Pramod Sharma, Ph.D., whose career spans LabCorp, Akorn, AMRI, Alvogen, and ImprimisRx (Harrow Health), and supported by regulatory affairs expertise from Madan Chilakuri, the firm brings direct experience across sterile and non-sterile dosage forms and global CMO partnerships in the Americas, Europe, and India.
Start with clarity. Build sustainable compliance into every next step — talk with Steripharm Solutions about your quality, compliance, and manufacturing objectives.
Contact our team → Steripharm Solutions Contact Page
