FDA Compliance
We help you build inspection-ready quality systems and respond with confidence — Form 483 responses, Warning Letter remediation, mock pre-approval audits, vendor audits, and regulatory submission reviews.
FDA Compliance & CGMP Quality Consulting for Pharmaceutical Manufacturers
We help sterile and non-sterile drug manufacturers build CGMP-compliant quality systems — from FDA 483 responses and Warning Letter remediation to batch record review, CAPA, and technology transfer — without slowing down your business objectives.
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 FDA-regulated pharmaceutical manufacturers.
From sterile injectables to oral dosage forms, our consulting and training services help sterile and non-sterile drug manufacturers achieve business objectives without compromising regulatory compliance.
- CGMP quality system development & implementation
- FDA inspection readiness & remediation support
- Training for sterile and non-sterile manufacturing teams
What 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 support manufacturing and product quality continuity through batch disposition, deviation investigations, CAPA, technology transfer, method validation, and environmental monitoring.
Why Steripharm
Clarity for complex
quality environments.
Focused consulting for the moments when product quality, business continuity, and regulatory expectations meet.
Business objectives, protected
Practical quality work that keeps regulatory compliance central to your business objective — so growth and inspection-readiness move together, not apart.
Experience across dosage forms
Deep expertise spanning sterile injectables, ophthalmic and otic products, oral dosage forms, and transdermal and transmucosal drug products.
Global perspective
Project and partnership experience with pharmaceutical manufacturers and CMOs across 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
Quality systems support across the full lifecycle of branded and generic pharmaceutical manufacturing.
OTC
drugs
CGMP compliance and quality consulting tailored to over-the-counter drug manufacturers.
Compounded
drugs
Practical regulatory and quality guidance for 503A/503B compounding facilities.
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
We understand your quality, manufacturing, and business objectives — and the regulatory pressure points around them.
Our services → - 02
Assess
We focus the work around your existing systems, records, and current regulatory expectations, including gap assessments.
FDA compliance → - 03
Strengthen
We support practical remediation, day-to-day quality operations, CAPA execution, and hands-on staff training.
Quality assurance → - 04
Sustain
We help you build toward mature, self-sustaining quality management systems designed for long-term compliance.
How we engage →
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.
Explore FDA complianceBetter continuity for manufacturing and product quality.
From disposition and batch record review to investigations, CAPA, technology transfer, method validation, and environmental monitoring.
Explore quality servicesA closer look
Quality is the
business advantage.
Watch how practical, business-aligned quality systems help pharmaceutical manufacturers stay inspection-ready while protecting speed to market.
Learn how Steripharm Solutions approaches CGMP compliance as a growth advantage, not a bottleneck.
Founder &President
Leadership
Guided by a life
in quality.
Pramod Sharma, Ph.D., is a senior-level industry leader with deep expertise in quality systems for both Rx and OTC pharmaceutical products.
His experience spans setting up quality systems in new manufacturing facilities, optimizing existing CGMP systems, and managing CMO projects and partnerships across the Americas, Europe, and India.
Meet our leadershipRepresentative work
Engagements that move
quality forward.
The kinds of quality and compliance challenges Steripharm Solutions is engaged to solve.
Regulatory response
Form 483 and Warning Letter responses paired with remediation plans that address root cause — designed to hold up at the next inspection.
Inspection readiness
Mock pre-approval audits that mirror real inspection conditions, surfacing documentation, procedure, and facility gaps while there is time to fix them.
Manufacturing continuity
Batch record review, investigations, CAPA, technology transfer, and environmental monitoring support that keeps release timelines on track.
Trusted by teams across branded, generic, OTC, and compounded drug manufacturing — including CMO partnerships in the Americas, Europe, and India.
Client benefits
A partnership built for
what comes next.
Transparent
Clear conversations and quality work centered on your regulatory objective, from day one.
Flexible
Experience brought to sterile and non-sterile drug manufacturing environments of every scale.
Accurate
Quality and compliance support built around detailed, practical execution — not generic checklists.
Our values: transparency, innovation, flexibility, speed, accuracy, and ethics.
FAQ
Common questions on FDA compliance and quality consulting.
Answers to the questions manufacturers ask most before starting an engagement.
Ask a different questionWhat does a CGMP quality consultant actually do?
A CGMP quality consultant helps pharmaceutical manufacturers design, implement, and sustain quality management systems that meet FDA regulatory expectations — covering everything from SOPs to inspection readiness.
Do you work with both sterile and non-sterile manufacturers?
Yes. Our consulting and training services support sterile injectable manufacturers as well as non-sterile oral, topical, and transdermal drug manufacturers.
Can you help respond to an FDA Form 483 or Warning Letter?
Yes. We support remediation planning and response drafting for Form 483 observations and FDA Warning Letters.
What industries and dosage forms do you specialize in?
Sterile injectables, ophthalmic and otic products, oral dosage forms, and transdermal/transmucosal products across branded, generic, OTC, and compounded drugs.
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.
Insights
The latest from
Steripharm.
News, perspectives, and quality insights from our team.
Blog
Hello world!
Welcome to WordPress. This is your first post. Edit or delete it, then start writing!
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News
CGMP 4.0
Our founder Pramod Sharma recently evaluated assisted, augmented, and virtual reality devices for applications in the FDA regulated Life Sciences industries.
Read moreCGMP 4.0
