"I am terrified we are going to fail our next inspection because my team is too stretched to see our own blind spots — I just need someone who has actually been in the trenches for twenty years to come in and tell me exactly what's broken before the FDA does."
— VP of Quality, Mid-Cap Pharma Manufacturer · PA/NJ Life Sciences Corridor
"We are short of auditing resources to meet our supplier, contractor, and our own facilities audit schedule goals. I need an experienced auditor who has done it all to help us meet our auditing goals."
— VP of Quality & Compliance, Small Biotech Manufacturer · North Carolina Research Triangle
"We are a small company in need of an experienced mentor to help me remediate some of the GMP areas in my facility, conduct targeted assessments, collaborate with my team, and draft realistic and effective remediation plans around our constraints."
— VP of Quality, Small Pre-IND Manufacturer · San Diego
I come to your facility before the regulatory agencies do and find the gaps your team is too stretched to see — or step in after a regulatory inspection in need of remediation — and I build a prioritized remediation roadmap with you.
Implement the roadmap fully — and if the regulator issues a Warning Letter or similar notice on a deficiency I identified within the scope of my audit, assessment, or consultation, after a fully documented remediation implementation, I refund your engagement fee.
Subject to the terms of the engagement letter.
Sarah has already tried the alternatives. Here is what that experience actually looks like — and what working with us looks like instead.
Every engagement is scoped to your situation. No generic packages. Roberto personally leads every engagement from day one to final verification.
Initial, routine, directed (for-cause), and Pre-Approval Inspection (PAI) audits for suppliers, contractors, and manufacturing facilities. Full written assessment, prioritized findings, and regulatory mapping to FDA 21 CFR 210/211, 820, EMA, Health Canada, and regional BOH standards. Roberto as Lead Auditor — not a project manager.
Full vendor approval programs: technical requirements, qualification audits, performance evaluation, and ongoing surveillance across domestic and international supply chains. Five global regions. Especially strong in complex biologics and CMO qualification across Latin America, Europe, and Asia.
Design and implementation of internal audit programs, audit guides, conformance assessment checklists, change control systems, and QTS frameworks. Auditor training development and deployment. Built these systems at Pfizer and Wyeth for global programs covering hundreds of suppliers.
Crisis-level remediation leadership for FDA Warning Letters and Consent Decrees, and comparable enforcement actions from international regulators. On-site management across aseptic operations, data integrity, pharmaceutical operations, and biologics manufacturing. Full CAPA implementation, verification, and regulatory submission support. 100% CAPA closure rate across all engagements.
Comprehensive PAI readiness for pharmaceutical, biologic, and medical device products. Mock FDA inspection, gap identification, remediation roadmap, and pre-inspection walkthrough. You will not be surprised by what the investigator finds — because Roberto found it first.
Preparation and defense of IND CMC sections, regulatory filing strategy, and direct FDA interaction support. Roberto has personally prepared and submitted three IND applications and interacted directly with the FDA in Washington D.C. — practical knowledge no textbook can replicate.
GMP Auditing & Consulting LLC was founded on a singular mission: to support the development and manufacture of safe and effective medical products for the treatment and prevention of human and animal diseases.
Roberto spent 24 years at Pfizer and Wyeth as Senior Audit Manager II, leading the Manufacturing and Supplier Quality Assessments Group across biotech, pharmaceutical, nutritional, medical device, consumer healthcare, and veterinary product suppliers on five continents. Before that, he served as Director of Operations at Allergenics Inc., where he invented a novel oral vaccine formulation that produced an unexpected anti-cancer immune response — tested at the National Cancer Institute, with patents issued.
His career spans every major regulated product category and every major pharmaceutical regulatory body. He has personally performed Initial, Routine, Directed, and PAI audits. He has prepared and defended IND CMC applications directly with the FDA in Washington D.C. He has led remediation programs for aseptic operations, pharmaceutical facilities, biologics, biotechnology products, and data integrity failures.
The number that matters most: zero closed CAPAs in Warning Letters. Every corrective and preventive action Roberto has ever touched has held up under subsequent regulatory inspection — never reopened, never cited in a Warning Letter. That is the track record behind the Zero Warning Letter Guarantee.
Roberto holds a B.S. in Biology (Magna Cum Laude) and an MBA in General Management (Magna Cum Laude), and seven ASQ certifications including the rare CMQOE (Certified Manager of Quality and Organizational Excellence). Bilingual in English and Spanish, available for engagements across the Americas, Europe, India, China, Australia, and New Zealand.
Four decades of hands-on experience across every major pharmaceutical and biotechnology GMP discipline.
Over four decades of progressive leadership at the most recognized names in global pharma — the judgment no textbook can replicate.
I partner with pharmaceutical, biologics, medical device, consumer healthcare and contract development and manufacturing organizations to close compliance gaps, reduce regulatory risk, and build quality systems that hold up under inspection — not just on paper, but in practice. My goal is straightforward: equip your team with clear, actionable solutions so you can focus on delivering safe, effective products to market with confidence.
Member of the Manufacturing and Supplier Quality Assessments Group. Led cGMP compliance assessments of domestic and international biotech, pharmaceutical, nutritional, medical device, consumer healthcare, and veterinary product suppliers across five global regions. Lead Auditor for Initial, Routine, Directed, PAI, and Facility audits.
Member of Wyeth Global Compliance Auditing Group. Division representative to Consumer Healthcare Quality Councils. Developed audit plans, guides, conformance assessment checklists, and auditor training programs covering a global supplier network across US, Canada, Europe, Asia, and Latin America.
Translated a university research project into a functional GMP corporate manufacturing operation. Invented a novel oral vaccine formulation producing an unexpected anti-cancer immune response — tested at the National Cancer Institute, patents issued. Prepared and defended three IND applications directly with the FDA in Washington D.C.
Coordinated enzyme technology transfer between Cincinnati, Latin America, Asia/Japan, and Europe R&D centers. Managed contract manufacturing QA operations in Puerto Rico and the Caribbean. Supported new product line introductions following the Noxell acquisition.
Full QA responsibility: product testing, process validations, vendor audits, statistical process control, specification approval, label control, and equipment qualifications for liquids, creams, and ointments manufacturing.
Oversaw chemistry, microbiology, pyrogen, particle testing, calibrations, and sterilizer qualification labs for large volume parenterals and medical devices. Microbiological troubleshooting of aseptic filling operations and critical plant systems.
Established the Biochemical Operations Fermentation Laboratory for Tobramycin antibiotic manufacturing plant start-up. Designed yield optimization experiments achieving a 30% increase in product yield. QA chemistry and technical services for enzyme-based diagnostic reagents.
Cross-sector expertise means Roberto doesn't just know your regulations — he understands how they interact with your operational reality.
Every fee below sits under Big Four market rate — and carries a money-back guarantee the Big Four will never offer. Travel and reasonable expenses are billed at cost outside the Philadelphia metro area.
A single FDA Warning Letter costs a mid-cap manufacturer $5M–$50M in remediation, lost revenue, shutdowns, and legal fees — before reputational damage. A Consent Decree can exceed $100M. A full remediation engagement at $180,000 is less than one day of production revenue at most mid-size facilities — with a money-back guarantee attached to it.
Every engagement runs against a signed engagement letter and a numbered invoice. Payment is by ACH bank transfer or wire — the two methods your treasury team already uses for vendor payments. Purchase orders, W-9, certificate of insurance, and Net 30 terms are all supported for enterprise vendor onboarding.
"I just need someone who has actually been in the trenches for twenty years to tell me exactly what's broken before the FDA does."
If that sounds familiar, you're exactly who we work with. Most engagements are scoped and started within two weeks. Roberto responds personally within one business day.