GMP Auditing &
Consulting LLC
Est. 2026

Before the FDA or regulators find it,
I provide independent GMP audits and assessments.

Supplier, contractor, CDMO, facility, and investigational medicinal product manufacturer audits, quality documentation and backlog support, and ISO/IEC 17025 laboratory assessments — so critical GMP work gets the experienced, independent judgment it needs, before someone else has to find the gaps for you. Led personally by Roberto L. Rivera, former Pfizer Senior Audit Manager II with four decades in cGMP and 24 years auditing.

See How I Can Help Start a Conversation
Find Your Situation

Which of these sounds like today?

Composite situations drawn from four decades in cGMP — not client testimonials.

Audits & Assessments
01

"If I don't get this done and something slips through on an unaudited supplier, that's on me — nobody's going to remember the budget conversation."

— VP of Quality · meeting an annual supplier audit schedule

02

"If something goes wrong on their floor, it's still my product with my company's name on it — and I'm the one who has to explain it, to my boss, to the customer, maybe to the regulator."

— VP of Quality · product manufactured by a third-party CDMO

03

"I don't need someone to tell me we have gaps — I need to know which ones to fix first, before the inspectors walk in."

— Director of Quality · preparing for an upcoming inspection

Quality Documentation Backlog
04

"If an investigator walked in tomorrow and asked what's still open, I honestly don't know what we'd hand them. That's the part that keeps me up."

— Director of Quality · established manufacturer, understaffed QA group

Specialized Assessments
05

"We've got contracts that require accreditation. If we don't pass, we don't keep them. And I can't tell from inside this lab whether we'd actually pass."

— Laboratory Director · pursuing ISO/IEC 17025 accreditation

06

"This is going into patients in a trial. If something's wrong at that manufacturer and I signed off on them, I don't know how I explain that to anybody."

— VP of Quality · clinical-stage biopharmaceutical company

Four DecadescGMP Experience
24Years GMP Auditing
7ASQ Certifications
5Continents Audited
CBACQACQE CPGPCHACMQOE CSSGBISO 17025
Which One Sounds Like You

Which one is closer to your situation?

Most of what lands on my desk falls into one of two categories.

Capacity
I need hands to work through it.

Investigations, CAPAs, change controls, and validation documentation are aging, and a team already stretched by daily operations cannot safely absorb any more.

See Quality Documentation & Backlog Support →
Independence
I need an independent read on the risk.

A supplier, CDMO, facility, laboratory, or investigational medicinal product manufacturer needs an objective assessment, and your internal team lacks the time or the distance to do it thoroughly.

See Audits & Assessments →
GMP Auditing & Consulting LLC
The Zero Warning Letter Guarantee
Independent GMP Audits, Assessments, and Backlog Remediations — Before the FDA or Regulators Find the Gaps

I audit your suppliers, contractors, laboratories, and facilities before the regulators do — and I find what a team that cannot safely absorb the work is bound to miss. Every audit closes with a prioritized findings report and a remediation roadmap your team can actually execute.

Implement that roadmap fully — and if a regulator issues a Warning Letter or similar notice on a deficiency I identified within the scope of my audit or assessment, after a fully documented remediation implementation, I refund your engagement fee.
Subject to the terms of the engagement letter.

Why Roberto, Not a Big Firm

The difference between real help and a checklist someone filled in

You have already tried the alternatives. Here is what that experience looks like — and what working with me looks like instead.

✗   The Big Four, Generic Consultancies & Staffing Agencies
✗
You speak to a partner; a 26-year-old associate shows up. They may never have personally qualified an API supplier, walked an aseptic suite, or challenged a CDMO on its own floor.
✗
A staffing agency sends a body, not judgment. Someone who needs weeks of training on your quality system before they can close a single investigation — and whose closures you then have to re-review yourself.
✗
The deliverable is a filled-in checklist that tells you nothing your own team could not have written — and no qualification recommendation you can actually act on.
✗
Comfort-zone auditing. Less experienced contractors tell you what you want to hear. Your supply chain's blind spots stay blind until an investigator finds them for you.
✗
Exorbitant fees with zero accountability. They charge a premium, leave, and offer no guarantee on outcome. You own all the risk.
✗
One-size-fits-all scopes. No understanding of your product type, supplier geography, or regulatory history. The work feels generic because it is.
✓   GMP Auditing & Consulting LLC
✓
I am the person who shows up — with 24 years of GMP auditing experience. I led audits and enhanced the supplier audit program at global scale as a Wyeth and Pfizer Senior Audit Manager II in the Manufacturing and Supplier Quality Assessment Group. Seven ASQ certifications. I have personally performed supplier, contractor, laboratory, and facility audits across five global regulatory regions.
✓
No learning curve on documentation work. I can open a batch record, an investigation file, or a validation package and immediately see what is missing — because I spent 24 years judging exactly that on behalf of a company FDA inspects constantly.
✓
Surgical, actionable findings — not generic templates. A prioritized written report mapped to the applicable regulations, and a clear audit rating your quality system can act on directly.
✓
Zero comfort-zone auditing. I find the threads that will unravel under regulatory scrutiny and tell you about them — even when it is uncomfortable. That is the job.
✓
Priced below the Big Four. Backed by a money-back guarantee. Senior expertise at a more reasonable cost than a Big 4-style consultancy — with skin in the game.
✓
Bilingual, global, cross-product. Pharma, biologics, gene therapy, medical devices, consumer healthcare, dietary supplements, and veterinary products — domestic and international supply chains, in English and Spanish.
✓
A deliberately limited client roster. As a solo practice, I take on a limited number of engagements at a time — so every client gets my direct, personal attention from the scoping call to final report, never handed off to a junior associate.
Audit & Compliance Support

Senior GMP help —
scoped to what you are actually behind on

Every situation above ends the same way: someone has to hand you something concrete. Here is exactly what that is. Every engagement is scoped to your situation — no generic packages, no long-term commitment — and I am the person doing the work, from day one to final report.

01
Quality Documentation & Backlog Support

Senior-level work on your backlog of complaint investigations, laboratory investigations, manufacturing investigations, CAPAs, change controls, and validation reports — worked to approval. Batch records worked to release. This includes backlog generated by a 483 or Warning Letter response: your team owns the response and the commitments to the agency, and I add senior capacity to work the documentation. Your team is already consumed by daily operations and the backlog keeps piling up. A growing backlog rarely announces itself — it keeps building quietly until someone outside your team asks to see it, and by then, catching up isn't a staffing problem anymore, it's a finding.

02
Supplier, API, Excipients, and Component Audits

A customized audit plan and a written audit report, issued within 30 calendar days. Findings and an audit rating — Acceptable, Conditionally Acceptable, or Unacceptable. Prior CAPA implementation is checked as part of your next scheduled audit cycle. 90 days of consultation on the findings; qualification decisions and remediation effectiveness remain with your own QMS.

03
Contractor & CDMO Audits

The same audit and reporting scheme applied to a CDMO's own manufacturing facility — drug products, biologics, and cell and gene therapy — typically 2–3 days, extending for multi-site operations involved in the audited product. Scope covers the CDMO's facility and their program for qualifying their own suppliers, not a physical audit of those third parties.

04
Facility & Internal GMP Audits

The same audit plan, report, and rating scheme applied to your own manufacturing facility and quality systems — an experienced, independent set of eyes with no loyalty to anyone on-site, mapped to FDA 21 CFR 210/211, 820, EMA, Health Canada, and regional standards, with findings that distinguish an isolated issue from a systemic risk, so you know not just what's wrong, but how urgently it needs to be fixed.

05
ISO/IEC 17025 Laboratory Assessments

Clause-by-clause laboratory assessment by an ACLASS ISO 17025 Lead Assessor. Findings cited using standard nonconformity classification — major nonconformity, minor nonconformity, observation — with an overall rating of Conformity, Non-conformity (Conditional), or Non-conformity (Critical).

06
Clinical Phase GMP Audits

The same audit, report, and rating scheme applied to suppliers, investigational medicinal product (IMP) manufacturers, and laboratories supporting Phase I, II, and III supply chains — audit depth and rigor calibrated to the clinical phase and the maturity of the process being reviewed.

Detailed Service Pages

Go deeper on a specific engagement

Each page covers what is included, how the engagement runs, and the questions clients ask most.

Supplier & CDMO Audits
View page →
Facility & Internal GMP Audits
View page →
ISO/IEC 17025 Laboratory Assessments
View page →
Auditorías GMP en Español
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About Roberto L. Rivera

Four decades in cGMP.
Five continents audited.

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.

When critical GMP work carries regulatory, business, product, patient, and personal consequences, the difference between managing that risk and being managed by it is experience and independence — brought to bear before a gap becomes someone else's discovery.

Roberto spent 24 years at Pfizer and Wyeth as Senior Audit Manager II, leading all types of GMP audits within the Manufacturing and Supplier Quality Assessments Group across biotech, pharmaceutical, nutritional, medical device, consumer healthcare, and veterinary product suppliers on five continents. That work included auditing suppliers, contract manufacturers, and manufacturing facilities supporting a global vaccine supply chain built at unprecedented speed — and leading a portion of the compliance remediation at a manufacturing site operating under a Warning Letter.

Before that, he served as Director of Operations at Allergenics Inc., where he developed a novel oral vaccine formulation that produced an enhanced immune response — tested at the National Institutes of Health, with patents issued to the company.

His experience spans every major regulated product category and every major pharmaceutical regulatory body. He has personally performed Initial, Routine, Directed, and Pre-Approval audits of suppliers, contractors, laboratories, and manufacturing facilities, and holds an ACLASS ISO/IEC 17025 Lead Assessor credential for laboratory competence assessment.

In December 2021, Pfizer presented Roberto with a Compliance Division Rewards & Recognition Award — signed by Pfizer's Chief Compliance, Quality & Risk Officer at the time — in recognition of exceptional work on "Delivering COVID Vaccine Audits & Inspections with Excellence."

The number that matters most: zero closed CAPAs cited in Warning Letters. Every corrective and preventive action arising from his audits has held up under subsequent regulatory inspection — never reopened, never cited. 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. Bilingual in English and Spanish, available across the Americas, Europe, India, China, Australia, and New Zealand.

GMP Auditing & Consulting LLC
Roberto L. Rivera
ASQ CBA · CHA · CMQOE · CPGP · CQA · CQE · CSSGB
B.S. Biology & MBA Management · Magna Cum Laude
ASQ Certifications
CBACertified Biomedical Auditor
CQACertified Quality Auditor
CQECertified Quality Engineer
CPGPCertified Pharmaceutical GMP Professional
CHACertified HACCP Auditor
CMQOECertified Manager of Quality & Org. Excellence
CSSGBCertified Six Sigma Green Belt
Accreditation
ISOACLASS ISO 17025 Lead Assessor
Coverage
WCWorkers' Compensation & Employer's Liability
PLMiscellaneous Professional Liability ($1M/$2M)
BOPBusiness Owner Policy
CLUCommercial Liability Umbrella ($1M/$2M)
Contact Information
(484) 868.4348
gmpauditingandconsultingllc@gmail.com
Malvern, PA · Global engagements
Technical Competencies

The depth behind every engagement

Twenty-four years of hands-on GMP auditing across every major pharmaceutical and biotechnology discipline — built on four decades in cGMP operations, quality, and manufacturing.

Quality Assurance & Auditing
Batch Record Review
Deviation Investigations
Change Control
Complaint Handling & Trending
Supplier Qualification
Contract Manufacturing
Global cGMP Auditing
ISO/IEC 17025 Assessment
Regulatory Compliance
Sterile Pharmaceuticals
Aseptic Processing
Biologics & Biotech
Gene Therapy
Class I, II, III Devices
Vaccines & Immunology
Fermentation Technology
Dietary Supplements
Diagnostic Reagents
Data Integrity
Sterilization Validation
Process Validation
Validation Documentation Review
Microbiology & Rapid Methods
Analytical Chemistry
Statistical Process Control
CAPA Systems
Technology Transfer
Clinical Phase Audits
Investigational Supply Chains
Professional History

A career built at the
world's most regulated facilities

Four decades of progressive leadership including some of the most recognized global pharma and medical device manufacturers — the judgement no regulation text can replicate.

2026 to PresentGMP Auditing & Consulting LLC — Malvern, PA
Founder & Principal Consultant

I partner with pharmaceutical, biologics, medical device, consumer healthcare, and contract development and manufacturing organizations to supplement their quality resources — clearing documentation backlogs, and auditing and qualifying suppliers, contractors, laboratories, and facilities.

Core Areas of Focus
  • Batch record review, investigation and CAPA closure, change control, and complaint handling support
  • Validation documentation review
  • Supplier, API, excipient, and CDMO audits and qualification
  • Contractor and manufacturing facility GMP audits
  • GMP laboratory audits and ISO/IEC 17025 assessments
  • Clinical Phase I, II, and III GMP audit support
  • Global GMP compliance gap assessments
2009 – 2026Pfizer, Inc. — Collegeville, PA
Senior Audit Manager II / Consumer Healthcare Quality Partner

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 — including audits of suppliers, contract manufacturers, and manufacturing facilities supporting a global vaccine supply chain established under extraordinary time pressure.

2002 – 2009Wyeth Pharmaceuticals — Collegeville, PA
Audit Manager (2002–2007) · Senior Audit Manager II (2007–2009) / Consumer Healthcare Business Partner

Member of Wyeth Global Compliance Auditing Group. Division representative to Consumer Healthcare Quality Councils. Led a portion of the compliance remediation for a manufacturing area operating under a Warning Letter. Developed audit plans, guides, conformance assessment checklists, and auditor training programs covering a global supplier network across US, Canada, Europe, Asia, and Latin America.

1993 – 1998Allergenics, Inc. — Cincinnati, OH
Director of Operations

Translated a university research project into a functional GMP corporate manufacturing operation. Developed a novel oral vaccine formulation producing an enhanced immune response — tested at the National Institutes of Health, with patents issued to the company.

1988 – 1993Procter & Gamble — Cincinnati, OH & San Juan, PR
Products Research Group Leader / Group Manager QA & Technical Services

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.

1985 – 1988Combe Products, Inc. — Humacao, PR
Quality Assurance Manager

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.

1981 – 1985Baxter — Maricao, PR
Quality Assurance Superintendent / Microbiology Laboratory Supervisor

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.

1976 – 1981Eli Lilly Industries / Coulter Biochemical — Puerto Rico
Fermentation Specialist / QA Chemist / Technical Services Supervisor

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.

Industries Served

If it's regulated,
I've audited it

Cross-sector audit experience means I don't just know your regulations — I understand how they interact with your operational reality.

Pharmaceuticals & Biopharmaceuticals
Sterile, solid dosage, topicals, liquids
21 CFR 210/211 · ICH Q7–Q10 · EU GMP · EU Annex 1
Biologics, Vaccines & Gene Therapy
Immunologics, viral vectors, ATMPs
21 CFR 600–680 · 21 CFR 1271 · ICH Q5
Medical Devices
Class I, II, and III devices
21 CFR 820 (QSR) · ISO 13485 · ISO 14971 · EU MDR
Nutritional Products & Dietary Supplements
Dietary supplements & functional foods
21 CFR 111 · 21 CFR 117 · ISO 22000 HACCP
Consumer Healthcare & OTC Products
Pfizer Consumer Healthcare · Wyeth pedigree
21 CFR 210/211 · 21 CFR 330 (OTC Monograph)
Diagnostic Reagents & IVDs
Enzyme-based & immunoassay reagents
21 CFR 809 · 21 CFR 820 · ISO 13485/17025
Cosmetics & Personal Care
Skin care, color & personal care
MoCRA · 21 CFR 700 · ISO 22716
Animal Health & Veterinary Products
Veterinary drugs & biologics
21 CFR 211/226 · 9 CFR · USDA APHIS
Contract Manufacturing Organizations
CMO/CDMO qualification & oversight
21 CFR 210/211 · ICH Q7 · ICH Q10
Investment

Transparent pricing.
No surprises.

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.

Most requested
Supplier & Contractor Audits
$2,250–$4,000 / day
1–3 day engagements
  • On-site Lead Auditor — me personally
  • Customized audit checklist & agenda
  • Real-time observations & daily debrief
  • Written findings report with regulatory mapping
  • Audit rating: Acceptable / Conditionally Acceptable / Unacceptable
  • 90 days of post-audit consultation
Scope this audit
Quality Documentation & Backlog Support
$250 / hour
Scoped to a defined backlog · remote or on-site
  • Complaint, laboratory, and manufacturing investigations — worked to approval
  • CAPA closure & documentation
  • Change control review & processing
  • Validation reports — worked to approval
  • Batch records — worked to release
  • Includes 483 / Warning Letter response backlog
  • Works to your SOPs and templates
Scope a backlog
Facility & Internal GMP Audits
$11,250 / week
1–2 week engagements
  • Full facility GMP compliance assessment
  • Gap analysis against current enforcement trends
  • Prioritized remediation roadmap — actionable, not generic
  • Executive summary for CEO & Board
  • 90-day remote advisory support post-report
  • Zero Warning Letter Guarantee applies
Book a facility audit
Additional Services
ISO/IEC 17025 Laboratory Assessment
Quoted per scope
Scoped to your testing
Clinical Phase GMP Audits
$250 / hour
Phase I, II, III

A backlog is a finding waiting to happen, and a single unqualified supplier can cost a mid-cap manufacturer millions in rejected lots, supply interruption, and regulatory findings that become your findings. Senior help is a fraction of that exposure.

2026 Fee Schedule (PDF) Request a Consultation
Client Payments
Pay an invoice, retainer, or engagement deposit

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.

ACH Bank Transfer Domestic & International Wire Purchase Orders · Net 30 Terms
Pay an Invoice Pay a Retainer
Before You Reach Out

The two questions every prospective client asks

Fair questions deserve direct answers — here is how the cost and the outcome actually work.

On Cost
"Can I actually justify this against my budget?"

Every fee on this site sits below Big Four market rate for work led personally by someone with 24 years of GMP auditing experience as a former Pfizer and Wyeth Senior Audit Manager II — not an associate a few years out of school. There is no partner markup, no team of juniors billed alongside a supervising partner, and no long-term retainer required to get started. A single supplier audit or a scoped backlog engagement is a defined, bounded cost you can compare directly against the cost of a rejected lot, a supply interruption, or a regulatory finding that becomes your finding. And it is the only offer in this market backed by a money-back guarantee tied to the outcome, not just the hours worked.

On Confidence It Will Work
"How do I know this will actually hold up for us?"

The honest answer is the track record: zero closed CAPAs from my audits have ever been cited in a subsequent Warning Letter. Every corrective action I have signed off on has held under later regulatory scrutiny. That track record was built over 24 years inside the Manufacturing and Supplier Quality Assessments Group at Pfizer and Wyeth — including a Pfizer Compliance Division Rewards & Recognition Award for my work on COVID vaccine audits and inspections, and a portion of the compliance remediation on a site operating under a Warning Letter.

That is also why the Zero Warning Letter Guarantee exists: if you fully implement the roadmap from an audit or assessment and a regulator still cites a deficiency within its scope, the engagement fee is refunded. Skin in the game, not just a promise. The engagement is also backed by a Miscellaneous Professional Liability policy and a Commercial Liability Umbrella, providing $1M/$2M in coverage.

Get In Touch

Get a Clearer View of Your GMP Challenge

Tell me what you're behind on. I have almost certainly seen it before.

"I just need someone who has actually been in the trenches for decades to look at this and tell me exactly what's there — before the FDA does."

If that sounds familiar, schedule a complimentary GMP Quality Risk & Capacity Assessment — a focused 30-minute conversation, not a sales call. We'll cover:

  • The specific GMP or Quality challenge you're facing
  • Where critical work is accumulating, or oversight may be thin
  • Whether the core issue is capacity, independent judgment, or both
  • The risk of continued delay
  • Practical next steps

You'll leave with a clearer picture of your situation and what to do next — no obligation to engage further. Most engagements are scoped and scheduled within two weeks. I respond personally within one business day.

Ready when you are.

GMP Quality Risk & Capacity Assessment
Location
Malvern, PA
Languages & Reach
English & Spanish · Americas, Europe, Asia-Pacific
Professional Affiliations
  • ASQ — American Society for Quality
  • PDA — Parenteral Drug Association
  • ISPE — International Society for Pharmaceutical Engineering
Request a Consultation
I respond personally within one business day.

Please keep your message general — just enough for me to understand your needs and reach out. Do not include confidential, proprietary, or client-sensitive information here. Any sensitive materials can be shared securely once a mutual confidentiality agreement is in place.

Your inquiry is confidential. I reply personally within one business day. A mutual NDA can be executed before any detail is shared.