FDA Compliance
We help you develop mature quality management systems for sustainable compliance.
Product quality.
Business integrity.
We help you achieve business objectives without compromising regulatory compliance. We help you sell quality.
FDA-regulated
quality systems
Sterile & non-sterile
drug manufacturers
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Quality first.
Always.
Always.
Steripharm Solutions LLC™
Compliance with the confidence to move forward.
We are experts at developing and implementing CGMP quality management systems for the FDA regulated industry.
We assure that your business objectives are achieved without compromising regulatory compliance. Our consulting and training services support both sterile and non-sterile drug manufacturers.
Discover our approachWhat we do
Quality systems that
stand up to scrutiny.
Focused consulting for the moments when product quality, business continuity, and regulatory expectations meet.
Quality Assurance & Quality Control
We help you overcome business disruptions associated with manufacturing or product quality.
Why Steripharm
Clarity for complex
quality environments.
Business objectives, protected
Practical quality work that keeps regulatory compliance central to the business objective.
Experience across dosage forms
Expertise spanning sterile injectables, ophthalmic and otic products, oral dosage forms, and transdermal and transmucosal products.
Global perspective
Project and partnership experience with organizations in the Americas, Europe, and India.
Industries served
For the products people depend on.
Specialist consulting and training for FDA-regulated drug manufacturers across branded, generic, OTC, and compounded medicines.
Talk to an expertBranded &
generic drugs
↗OTC
drugs
↗Compounded
drugs
↗Our approach
From immediate need
to sustainable practice.
A clear engagement path keeps attention on the work that matters: mature systems, quality continuity, and compliance.
- 01
Listen
Understand the quality, manufacturing, and business objective in view.
- 02
Assess
Focus the work around systems, records, and regulatory expectations.
- 03
Strengthen
Support practical remediation, quality operations, and training.
- 04
Sustain
Build toward mature quality management systems and sustainable compliance.
Compliance & quality
Built around the standards
that protect patients.
Inspection-ready systems, made practical.
Support for Form 483 and Warning Letter responses, remediation plans, mock pre-approval audits, vendor audits, due diligence, and regulatory submissions review.
Better continuity for manufacturing and product quality.
From disposition and batch record review to investigations, CAPA, technology transfer, method validation, and environmental monitoring.
A closer look
Quality is the
business advantage.
Founder &President
Leadership
Guided by a life
in quality.
Pramod Sharma, Ph.D., is a senior level industry leader with expertise in the quality systems for both Rx and OTC products.
His experience includes setting up quality systems in new facilities, optimizing existing systems, and managing CMO projects and partnerships in the Americas, Europe, and India.
Meet our leadershipClient benefits
A partnership built for
what comes next.
Transparent
Clear conversations and quality work centered on the objective.
Flexible
Experience brought to sterile and non-sterile drug manufacturing environments.
Accurate
Quality and compliance support built around detailed, practical execution.
Our values: transparency, innovation, flexibility, speed, accuracy, and ethics.
Start with clarity
Build sustainable compliance into every next step.
Talk with Steripharm Solutions about your quality, compliance, and manufacturing objectives.
Get in touch
Let’s make quality
your advantage.
Tell us about your quality, compliance, or manufacturing objective.
- Phone217-848-1814
- Emailinfo@steripharmsolutions.com
