EPR Consulting LLC — Essential Pharmaceutical Resilience

The Proposed Endeavor

Two integrated lines of work

The proposed endeavor is designed to improve medication access, pharmaceutical supply resilience, and pharmacy operational capacity through two integrated lines of work: Pharmaceutical Manufacturing and Compounding Consulting for 503A/503B, health-system, and pharmacy-based production environments; and TECH-ROB, a pharmacist-supervised automated robotic dispensing system designed to support telepharmacy, traceability, and access in underserved or resource-constrained communities.

EPR's mission is to help strengthen the safe, efficient, and traceable production and delivery of essential medications in alignment with U.S. public-health priorities, domestic pharmaceutical resilience, and medication-access needs.

Regulatory Notice

EPR Consulting LLC is not currently operating as a pharmacy and does not dispense prescriptions. Any future dispensing, verification, counseling, or clinical pharmacy activity in the United States will be performed only by properly licensed U.S. pharmacists and authorized pharmacy or healthcare partners, subject to applicable federal and state law, Board of Pharmacy requirements, facility licensing, and site-specific approvals.

About the Founder

Miguel Ángel Romera Bueno

Pharmacist & Pharmaceutical Manufacturing Specialist

20+ years in pharmacy operations & compounding
Technical Director & principal owner, Farmacia Patagonia S.C.S. (Argentina)
Pharmaceutical manufacturing & quality practices
Pharmacy automation & dispensing-process improvement
Proposed Founder — EPR Consulting LLC

Miguel Ángel Romera Bueno is a pharmacist licensed in Argentina with more than twenty years of professional experience in pharmacy operations, pharmaceutical compounding, medication management, pharmacy workflow optimization, and manufacturing-related quality practices.

He has served as Technical Director, administrator, and principal owner of Farmacia Patagonia S.C.S. in Argentina, where he developed extensive experience across pharmacy operations and regulatory compliance; pharmaceutical compounding and formulation activities; medication procurement and inventory management; supplier coordination and purchasing workflows; pharmacy workflow modernization; implementation of computer systems and pharmacy-management software; quality-assurance practices and documentation; and pharmacy automation and dispensing-process improvement.

Miguel's proposed U.S. endeavor builds on this background by combining pharmaceutical manufacturing consulting, compounding-process optimization, and pharmacist-supervised automation through TECH-ROB.

Non-Clinical Role

Miguel's proposed U.S. role is non-clinical: pharmaceutical manufacturing consulting, quality systems, validation, automation implementation, traceability, and KPI governance. Any dispensing or patient counseling will be performed by U.S.-licensed pharmacists or authorized partner entities.

AConsulting

Pharmaceutical Manufacturing & Quality Consulting

Building reliable, auditable, shortage-ready pharmaceutical operations

EPR's first operational line is designed to support U.S. compounding pharmacies, outsourcing facilities, health-system pharmacies, and related pharmaceutical operations seeking to improve quality, efficiency, traceability, and shortage-response readiness.

TDP 6s Desktop Tablet Press — single punch desktop format pill press

TDP 6s · Single punch desktop tablet press

TDP 1.5 Desktop Tablet Press — flexible desktop pill press

TDP 1.5 · Desktop tablet press · High flexibility

DTP 25 Desktop Tablet Press — advanced enclosed tablet pressing system

DTP 25 · Advanced enclosed desktop tablet press

Rotary tablet press lineup — RTP 33, RTP 118, RTP 41, RTP 10i high-volume production machines

Rotary tablet press lineup · RTP series · High-volume pharmaceutical production

Proposed consulting services

503A/503B operational-readiness support

cGMP-oriented quality-system implementation

SOP development and documentation control

Electronic batch record & traceability framework design

CAPA and deviation-management support

IQ/OQ/PQ validation framework assistance

Compounding-process optimization

Solid-dosage workflow improvement

Inventory and supply-chain process review

Inspection-readiness and remediation support

Staff workflow and training-system design

The objective is to help pharmacy and compounding environments become more reliable, auditable, efficient, and responsive to medication-access needs.

Line A — Compounding Production Capacity

Supporting solid-dosage and compounding environments

EPR's consulting line includes workflow optimization, GMP-aware documentation, SOPs, batch-record systems, and solid-dosage production improvement for compounding environments — helping facilities become more reliable, traceable, and inspection-ready.

⬡Workflow optimization

⬡GMP-aware documentation

⬡SOP development

⬡Electronic batch records

⬡Solid-dosage production improvement

⬡Inspection-readiness support

Compliance Notice

EPR's consulting services do not replace legal, regulatory, or Board of Pharmacy advice. Any implementation in the United States must be performed in compliance with applicable federal and state law, FDA requirements, USP standards, Board of Pharmacy rules, facility licensure, and partner-specific compliance protocols.

BTECH-ROB

Automated Robotic Dispensing System

TECH-ROB

TECH-ROB is an automated robotic dispensing system developed by pharmacist Miguel Ángel Romera Bueno to support safe, traceable, and pharmacist-supervised medication access in settings where traditional pharmacy infrastructure may be limited.

TECH-ROB is designed to store, identify, retrieve, and dispense pre-manufactured medication packages under authorized pharmacy supervision. It is not a manufacturing system and does not compound medications — any compounding or manufacturing-related activities belong to EPR's Line A consulting work and must occur only at properly licensed facilities.

TECH-ROB automated dispensing robot — real pharmacy deployment with cartesian gripper and medication shelves

TECH-ROB · Automated dispensing with cartesian gripper & medication shelves

TECH-ROB system architecture — 3D diagram showing cartesian gantry, shelves, pinch head and electrical equipment

TECH-ROB · System architecture — Cartesian gantry, shelves & pinch head

TECH-ROB internal structure — clamp head linear guide X-axis and Z-axis motion system

TECH-ROB · Clamp head & linear guide axes (X / Z motion)

TECH-ROB gripper mechanism — clamp closure, 180° platform rotation and Y-axis advance

TECH-ROB · Gripper clamp closure & 180° platform rotation

Key Technical Features

TECH-ROB has been designed around:

Cartesian robotic motion architecture
Automated pick-and-place handling of medication packages
Barcode and label recognition
OAK-D / OAK-D Pro AI-assisted vision concepts
Hybrid sensing — traditional sensors and computer vision
Lot and expiration-date traceability
Electronic transaction logging
Inventory visibility and stock-status controls
Software integration readiness with pharmacy ERP/POS workflows
Remote pharmacist-supervised verification workflow
Modular hardware and cost-conscious deployment design

Intended Use

TECH-ROB is intended for controlled pilot deployment in legally authorized settings such as pharmacies, clinics, health-system sites, or other eligible locations where state law permits pharmacist-supervised remote dispensing, RAMS, APS, telepharmacy, or similar models.

Potential future deployment environments may include:

Rural / underserved communities Community clinics Health-system pharmacy nodes Eligible long-term care / hospice Pharmacy-desert locations After-hours partner pharmacies Traceable supervised pickup

Regulatory Notice

TECH-ROB deployment in the United States is subject to state-specific law, Board of Pharmacy approval, site eligibility, facility licensure, pharmacist supervision, medication-scope restrictions, data-privacy requirements, and applicable federal and state compliance obligations.

Public Health Purpose

Medication access, resilience, and traceability

Medication shortages & supply fragility

Addressed by supporting quality, documentation, and operational capacity in pharmaceutical and compounding environments.

Pharmacy deserts & access gaps

Addressed by developing pharmacist-supervised automated dispensing technology for underserved locations.

Cost-driven non-adherence

Addressed by supporting more efficient medication workflows, transparent access models, and lower-cost operational pathways.

Measurable Outcomes

Site-level and system-level KPIs

Medication availability Fill-rate Adherence No-pickup / abandonment rate Time-to-therapy Documentation completeness CAPA closure Operational uptime Patient access in underserved areas Shortage-response readiness

Development Status

Where the project stands

TECH-ROB has progressed through technical design, prototype development, bench-level functional validation, cost modeling, and regulatory-readiness mapping. Current project status includes:

Completed

Technical architecture developed

Completed

Robotic motion and pick-and-place concepts documented

Completed

OAK-D / AI vision integration designed and documented within the prototype architecture

Completed

PostgreSQL-based traceability and inventory-control architecture documented

Completed

SOP and IQ/OQ/PQ framework drafted

Completed

RAMS / APS / telepharmacy regulatory pathways mapped in selected states

Completed

Cost bridge developed from prototype BOM to pilot-ready CAPEX

Completed

External technical validation obtained from engineering and technology professionals

Completed

Pharmacy workflow validation experience supported by WinFarma64 collaboration

Next Stage

Controlled pilot-readiness work — site selection, partner discussions, state-specific regulatory review, Board of Pharmacy requirements, documentation finalization, performance qualification, and KPI reporting.

WinFarma64 Collaboration

Pharmacy workflow validation & automation readiness

Before developing the U.S. implementation model for EPR and TECH-ROB, Miguel Ángel Romera Bueno collaborated with WinFarma64, a pharmacy-management software platform used by more than 250 pharmacies across Argentina.

Farmacia Patagonia S.C.S. served as a real-world pilot environment for pharmacy workflow validation, administrative-process review, billing logic, inventory-control concepts, and automation-readiness analysis.

Miguel's contribution to WinFarma64 involved pharmacy workflow validation, billing logic, inventory-control concepts, audit-readiness, and automation-readiness planning. This collaboration demonstrates experience translating real pharmacy operations into software-controlled systems — directly relevant to TECH-ROB's design requirements for product identification, stock visibility, traceability, and user-facing pharmacy operations.

Pharmacy workflow validation

Billing logic & administrative processes

Inventory-control concepts

Audit-readiness planning

Automation-readiness analysis

Software-process input

Important Clarification

WinFarma64 collaboration does not mean TECH-ROB is currently commercially deployed through WinFarma64. It demonstrates pharmacy workflow validation, software-process input, and automation-readiness planning.

250+

Pharmacies using the WinFarma64 platform

Evidence-Based Readiness

Documentation, validation & regulatory preparedness

EPR's proposed model is supported by technical documentation, prototype validation, SOP/IQ/OQ/PQ planning, regulatory-readiness mapping, and pharmacy workflow validation through WinFarma64.

Technical Documentation

Architecture specs, robotic motion design, OAK-D vision integration, PostgreSQL traceability schema, and cost bridge from prototype BOM to pilot-ready CAPEX.

Prototype Validation

Bench-level functional validation completed. External technical validation obtained from engineering and technology professionals.

SOP / IQ / OQ / PQ Framework

Standard operating procedures, installation qualification, operational qualification, and performance qualification framework drafted and ready for pilot-stage finalization.

Regulatory-Readiness Mapping

RAMS / APS / telepharmacy regulatory pathways mapped in selected states. Preliminary Board of Pharmacy diligence completed for Oregon (Pharmacy Prescription Kiosk framework) and Missouri (automated dispensing system rule). Compliance obligations documented.

Pharmacy Workflow Validation

Real-world operational experience through WinFarma64 collaboration — workflow validation, billing logic, inventory-control, audit-readiness, and automation-readiness planning.

Pilot Readiness — Next Stage

Site selection
State regulatory review
Board of Pharmacy pathway
SOP / eBR finalization
IQ / OQ / PQ completion
KPI reporting framework
Remote pharmacist workflow

Contact / Pilot Inquiries

Let's talk about readiness, pilots, and collaboration

For future pilot discussions, technical collaboration, consulting inquiries, or pharmacy automation readiness:

Proposed Founder

Miguel Ángel Romera Bueno
Pharmacist & Pharmaceutical Manufacturing Specialist
Proposed Founder — EPR Consulting LLC

[email protected]

Phone

+1 (904) 990-3431

Please Note

EPR Consulting LLC is a proposed U.S. entity to be formed upon EB-2 NIW approval. Any future service offering, pilot, installation, consulting engagement, or deployment will be subject to applicable licensing, regulatory, contractual, and professional requirements.