Panama · Central America · Caribbean · Colombia j.rosas@rosasqs.com
From Panama to Central America, the Caribbean and Colombia

Quality, compliance and secure supply chains

Consulting, audits, validations and training in management systems for the pharmaceutical, medical device, logistics and manufacturing industries.

15+years of experience in quality and logistics
Lead auditorISO 9001 · ISO 14001 · ISO 45001
BASC · AEOsupply chain security experience
3 regionsCentral America, the Caribbean and Colombia
Standards & frameworks
  • ISO 9001
  • ISO 14001
  • ISO 45001
  • ISO 13485
  • ISO 22000
  • ISO 28000
  • BASC
  • AEO
  • IATA CEIV Pharma
  • GxP (regional focus)
  • HACCP
Reviewing quality indicators
2022Founded in Panama on more than a decade of prior industry experience
Who we are

Your strategic partner for quality and regional compliance

Rosas Quality & Services is a Panamanian consulting firm that helps organizations comply with international standards and health regulations, protect their supply chain and succeed in audits and certifications.

We combine a certification auditor's perspective with hands-on experience leading quality, infrastructure and logistics functions in industry.

Regulatory complianceISO, GMP, BASC, AEO, FDA and RTCA.
An auditor's eyeWe know what gets assessed, and how.
Real logistics experienceDistribution, warehousing and cold chain.
Regional reachService in Spanish and English.
Service lines

End-to-end solutions for your organization

Six service lines that support you from training your team to validating your processes and achieving certification.

01

Consulting & implementation

Design and implementation of quality, environmental, OH&S, pharmaceutical and supply chain management systems.

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02

Audits

Internal, supplier and logistics provider audits, plus nonconformity management.

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03

Validations

DQ, IQ, OQ and PQ protocols and execution, temperature and humidity mapping, and microbiological testing.

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04

Training

Training programs on ISO standards, good practices, risk management, auditing and KPIs.

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05

Project management

Facility design, cold rooms, logistics centers, technology transfer and process implementation.

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06

Complaints management

Outsourced complaint handling, root cause analysis and incident advisory.

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Specialty

Logistics and supply chain security

Panama is the logistics hub of the Americas, and your operation must match that standard. We help logistics providers, distributors, warehouses, free zone companies and carriers protect cargo, meet customs and health requirements, and earn the trust of clients and authorities.

Our experience comes from leading quality in distribution, cargo and free-zone operations: BASC implementation, Authorized Economic Operator certification, refrigerated fleet validation and logistics center design.

BASCAuthorized Economic Operator (AEO)ISO 28000IATA CEIV PharmaGood Storage & Distribution Practices
Assess my operation

BASC & AEO

Implementation, internal audits and readiness for BASC certification and Authorized Economic Operator status.

Risk assessment

Risk assessment across the supply chain, business partners and routes, aligned with ISO 31000.

Cargo security

Controls against contamination and internal or external conspiracies in warehouses and road transport.

Cold chain

Validation of cold rooms and refrigerated fleets, thermal mapping and IATA CEIV Pharma requirements.

Dangerous goods

Handling of dangerous goods and substances under IATA DGR.

3PL & supplier audits

Assessment of third-party logistics providers, warehouses and carriers.

Consulting & implementation

Management systems that work

We support you through the diagnosis, design, documentation and implementation of systems aligned with international standards and your industry's regulations.

Quality

ISO 9001:2015

Environment

ISO 14001:2015

Occupational Health & Safety

ISO 45001:2018

Pharma & medical devices

RTCA 11.03.42:07FDAEudraLexISO 13485:2016

Logistics & supply chain

ISO 28000BASCAEOIATA CEIV Pharma
Industries

Sectors we serve

Pharmaceutical
Medical devices
Cosmetics
Logistics, distribution & multimodal transport
Warehouses & free zones
Food
Manufacturing
Private security
Methodology

How we work

A clear, measurable process from diagnosis to certification.

01

Gap analysis

We assess where you stand against the standard or regulation.

02

Roadmap

We set priorities, owners and timelines.

03

Implementation

We document, train and work alongside your team.

04

Verification

Internal audit and closure of nonconformities.

05

Certification & improvement

We prepare you for the external audit and continual improvement.

Our services

In detail

Reviewing reports during an audit
AUDITS

First- and second-party audits

We objectively assess your processes, suppliers and logistics providers with the experience of a certification lead auditor.

  • Audit programs and plans
  • Internal management system audits
  • Supplier, warehouse and carrier audits
  • Nonconformity follow-up and management
Inspector with a checklist
VALIDATIONS

Validation & qualification

We provide documented evidence that your equipment, facilities and processes perform as intended.

  • DQ, IQ, OQ and PQ protocol development
  • DQ, IQ, OQ and PQ execution and reporting
  • Temperature and humidity mapping of warehouses, cold rooms and vehicles
  • Gap resolution (drawings, pre-test technical inspection)
  • Microbiological testing
Auditorium during a training session
TRAINING

Training for your team

Practical courses so your people understand, apply and sustain key requirements.

  • ISO 9001:2015
  • ISO 14001:2015
  • ISO 45001:2018
  • ISO 13485:2016
  • RTCA 11.03.42:07
  • Risk management ISO 31000:2018
  • FDA GMP & distribution
  • EU GMP & distribution
  • HACCP analysis
  • Root cause analysis
  • Auditing techniques
  • Process-based procedures
  • KPI management
Gantt chart on a tablet
PROJECTS

Project management

We plan and oversee industrial and logistics projects so they are delivered on time and in compliance.

  • Design of facilities, warehouses and cold rooms
  • Technology transfer
  • Process implementation
  • Machinery and technology upgrades
  • Construction oversight for industry and logistics
Professional analyzing a case
COMPLAINTS

Complaint management

We handle customer complaints with technical rigor to find the root cause and prevent recurrence.

  • Outsourced complaint handling
  • Root cause analysis for complex cases
  • Incident advisory
Regional coverage

From Panama, across the region

Our Panama base lets us serve companies in Central America, the Dominican Republic, the Caribbean and Colombia quickly, on-site or remotely.

Panama Headquarters

Panama City, free trade zones and the country's logistics areas.

Central America & Dominican Republic

Guatemala, Belize, El Salvador, Honduras, Nicaragua, Costa Rica and the Dominican Republic.

The Caribbean

Cuba, Haiti, Jamaica, the Bahamas, Trinidad and Tobago, Barbados, Aruba, Curaçao and the other Caribbean nations and territories (excluding U.S. territories). Service in Spanish and English.

Colombia

Consulting and audits across the country's main cities and industries.

Central America + Dominican Rep. Caribbean Colombia PANAMA HEADQUARTERS
Countries we servePanama headquartersMap: Natural Earth
Founder

Industry experience, an auditor's perspective

José Rosas founded Rosas Quality & Services in 2022 after more than 13 years leading quality and infrastructure functions at leading distribution, cargo and pharmaceutical companies in Panama.

Today he combines consulting with his work as a certification lead auditor, giving every client a practical view of what is actually assessed in an audit.

  • General Manager / Technical Director — Rosas Quality & Services2022 – presentConsulting, first-, second- and third-party audits, validations, plant and warehouse design, and training.
  • Certification lead auditor2023 – presentISO 9001, 14001 and 45001 across Colombia, Panama and the Caribbean, including medical devices, pharmacy retail, cargo handling and warehousing.
  • Quality Director and Infrastructure Director — pharmaceutical sector, Free Zone2017 – 2022Authorized Economic Operator certification, transition to ISO 9001:2015, design and construction of cold rooms and a cryogenic logistics center, and a plant certified to ISO 9001 and ISO 13485.
  • Quality Coordinator and Manager — cargo operator2014 – 2017Management system implementation, ISO 9001 and BASC certifications, refrigerated fleet validation and new facility design.
  • Quality Coordinator and Head of Quality — food service distribution2009 – 2014Quality system implementation and Distribution Quality Management certification for a global restaurant chain.

Ready to strengthen your management system?

Tell us what you need and we will prepare a tailored proposal, anywhere in the region.

Request a proposal
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We work in Spanish and English. Reach us however you prefer.