Walk into audits ready
Know what a client auditor or FDA investigator will find before they arrive—and close the gaps that actually carry risk to the account.
Contract manufacturing · Pharma · OTC · Cosmetics
Your quality system wins accounts—or quietly loses them.
Every brand that audits your plant is deciding whether to keep the business. DayGen gives Florida contract manufacturers senior quality leadership on the floor—so client audits stay clean, FDA inspections stay uneventful and your lines keep running.
A direct reply from the principal consultant—typically within one business day. On-site visits scheduled across Florida.
What changes
Make quality a reason brands stay.
Not more binders. A system your supervisors actually run, your customers' auditors can follow and an FDA investigator can close out.
Build systems your floor will use
SOPs, batch records, training and accountability built for shift reality—so compliance survives turnover, changeovers and peak season.
Add capacity without adding headcount
Senior quality leadership when your QA manager is stretched thin, between roles or facing more client audits than the team can absorb.
Industry coverage
Three product categories. Often on the same plant floor.
Contract manufacturers rarely run just one category. DayGen covers Pharma, OTC and cosmetics together including the controls where lines, categories and customers meet.
Pharmaceuticals & OTC
Inspection readiness, cGMP systems, process and cleaning validation, supplier controls, investigations and remediation for drug and OTC lines.
21 CFR 210/211ICHData integrity
Dietary Supplements
Specifications, identity and strength controls, master manufacturing and batch production records, supplier qualification and 21 CFR 111 systems.
21 CFR 111Claims & labelsSpecifications
Cosmetics & Personal Care
ISO 22716 GMP programs, MoCRA readiness, safety documentation, complaints, adverse events and changeover controls for personal-care lines.
ISO 22716MoCRASafety substantiation
Core capabilities
From the first plant walkthrough to verified closure.
Bring DayGen in for a single audit or a specific finding or as ongoing senior quality capacity your plant does not have to carry full time.
FDA compliance & regulatory strategy
Determine what applies to each line, where the plant is exposed and how to build a defensible position—without stopping production to get there.
- Gap assessments & remediation plans
- FDA 483 and warning-letter response
- Contract-party responsibility agreements
- New-category and new-line scoping
Quality systems, QA/QC & compliance operations
Build or repair the system behind compliant execution—one QMS that holds across every brand, category and line the plant runs.
- QMS design, SOPs & forms
- CAPA, deviations & change control
- Specifications & batch records
- Operator training and management review
Client audits, FDA readiness & validation
Stress-test the plant before your customer’s auditor, a certification body or an FDA investigator does—then close the evidence trail behind every finding.
- Client audit preparation and hosting
- Mock FDA inspections
- Process, cleaning & equipment validation
- Findings closure and audit remediation
New product & customer onboarding
Take on a new brand or a new formula without importing its problems—quality, regulatory and manufacturability settled before the first commercial run.
- Technology transfer & scale-up controls
- Formula and ingredient risk review
- Client specification alignment
- Stability and shelf-life strategy
AI implementation for regulated operations
Select practical use cases, establish governance and implement private knowledge or workflow tools without bypassing quality oversight or exposing customer data.
- AI opportunity & risk assessment
- Private SOP knowledge assistants
- Vendor and data-control review
- Validation, change control & adoption
Differentiator
Very few quality consultants can also implement AI inside a validated environment. DayGen does both—so the controls come built in rather than bolted on, and your customers’ documents never leave your control.
Responsible AI implementation
Use AI to reduce friction—not to create a new compliance finding.
A multi-brand plant runs on documents hundreds of SOPs, specs and customer requirements. DayGen helps you move from experimentation to controlled use: a clear business case, defined intended use, protected client data, documented oversight and measurable adoption.
Private knowledge systems
Secure assistants that help authorized users find approved SOPs, forms, specifications and training content—grounded in controlled documents rather than public web results.
Quality workflow augmentation
Structured support for complaint intake, investigation preparation, CAPA trend review, audit readiness and document comparison—with controlled human review before action.
Governance and risk controls
Policies, use-case classification, access controls, data handling, vendor assessment, accuracy testing, incident response, change control and periodic performance review.
Implementation and adoption
Requirements, pilot design, acceptance criteria, role-based training, controlled deployment and effectiveness measures—so the tool becomes usable operating infrastructure.
Pharma & OTCSOP retrieval on the floor, batch-review support, investigation preparation and change-control research across lines.
Dietary supplementsSpecification and COA review support, supplier-document search, incoming-material checks and complaint classification.
CosmeticsMoCRA documentation organization, safety-file retrieval, adverse-event intake and formula/INCI knowledge search per customer.
Representative experience
Work built to survive a running plant.
Examples are described by scope rather than client name to protect confidential information and avoid unsupported marketing claims.
One quality system spanning FDA, ISO and GDP requirements
Quality manuals, procedures, forms, compliance matrices and training controls built as a single operating system that holds across every customer and category on the floor.
Technical gap analysis for product-strength specifications and analytical controls
Assessment of specification strategy, compendial methods, elemental-strength calculations, contract-party responsibilities and a defensible path toward remediation.
Validation programs that connect protocols, execution and continued control
Process validation, cleaning validation, equipment qualification, stability, environmental monitoring and annual-review infrastructure aligned to the operation.
Private document intelligence for SOP and form access
Multi-tenant knowledge architecture, role-based access concepts, controlled-document retrieval and assisted form workflows designed around private organizational content.
Engagement details, client identities and proprietary documentation remain confidential. Scope examples should be confirmed before public launch.
The person behind the work
Senior judgment without the big-firm handoff.
Cristobal brings more than 17 years of quality-assurance and compliance experience across pharmaceutical, OTC, dietary supplement and cosmetics manufacturing operations.
His work spans quality-system design, FDA and client audit readiness, validation, technical remediation, tech transfer and practical implementation. The approach is intentionally hands-on: walk the floor, read the records, make the risk visible, build the control and leave the team stronger than he found it.
He works primarily with Florida contract manufacturers the plants producing many brands under one roof, where a single quality system has to satisfy every customer, every category and the FDA at the same time.
That same quality mindset now extends to AI. DayGen helps organizations use emerging tools where they improve access, consistency and speed without losing control of approved content, regulated records or accountable decision-making.
Engagement model
A clear path from plant floor to closed finding.
No mystery retainer and no disappearing into a slide deck. Every engagement starts on your floor, with the decision that has to be made and the evidence needed to support it.
Walk the plant
See the lines, the records and the current state first hand—then rank exposure by what threatens accounts and uptime.
Scope
Define deliverables, responsibilities, timeline, dependencies and acceptance criteria before work begins.
Implement
Work directly in your documents, workflows and production areas—with your supervisors and QA staff involved throughout.
Verify
Confirm closure, evidence effectiveness and transfer knowledge so the system remains sustainable.
Common questions
What plant leadership asks first.
A short call is the fastest way to determine fit, timing and the right starting point.
Do you work with contract manufacturers or with brand owners?
Primarily with contract manufacturing plants, the operations producing many brands under one roof. That is a different problem from brand-side consulting: one quality system has to satisfy every customer’s requirements, several product categories and the FDA simultaneously.
We have a client audit coming up. Can you help us prepare?
Yes, and this is one of the most common reasons clients call. Preparation typically includes a mock audit against the customer’s expected scope, remediation of what can realistically be closed before the date, document and record readiness, and coaching for the team who will be in the room.
Our QA manager just left. Can you cover the gap?
Yes. DayGen can provide interim senior quality leadership keeping releases, deviations, CAPAs, customer commitments and audit obligations moving while you recruit, and handing over cleanly to the person you hire.
Can we start with one project rather than a long retainer?
Yes. Engagements are commonly scoped around a single audit, a validation package, a 483 or warning-letter response, a QMS build, a new customer onboarding or an AI pilot. Scope, deliverables and acceptance criteria are agreed before work begins.
Do you come to the plant?
Yes. DayGen is Miami-based and works on-site across Florida, floor assessments, audits, validation execution and inspection support all benefit from being there. Document development and review are handled remotely to keep cost down.
How is AI handled in a validated environment?
The starting point is intended use and risk. DayGen defines what the system may do, which customer data it may access, where human review is mandatory, how performance is tested, and how changes, incidents and records are controlled so it strengthens the operation instead of creating a new finding.
How quickly will I hear back?
Typical response within one business day. If you are facing an active FDA inspection, a 483 response deadline or an at-risk customer audit, say so up front and it moves to the top.
Start a conversation
What’s on your audit calendar?
Tell us what your plant runs, what’s coming up and the timing you will get a direct first response, not an intake sequence. Urgent inspection or customer-audit matters move to the front.