Denver: in person and remote • United States: remote • Languages: Spanish and English
16+
years of quality and operations experience
QMS
FDA · GMP · ISO · HACCP
360°
documentation, processes, inventory and technology
ES/EN
bilingual service
OUR APPROACH
From requirements to daily practice.
We do not create documents just to fill binders. We design solutions that fit the operation: clear responsibilities, usable records, traceable controls and teams that know what to do.
We combine Quality Assurance and regulatory compliance leadership with experience in systems, inventory, warehouse operations and digital platforms.
CORE SERVICES
Focused support where it matters most to your quality system.
The scope adapts to each company’s size, stage and risks.
01
QMS · GMP
Quality & GMP Compliance Consulting
Assessment of the current system, gap identification and a risk-prioritized action plan.
QMS implementation and improvement
21 CFR Parts 111 / 117
GMP, cGMP and performance indicators
02
DOCUMENT CONTROL
SOP & Quality Documentation
Creation, review and organization of clear, controlled documents aligned with real operations.
SOPs, WIs, policies and forms
Specifications and records
Master Manufacturing Records
03
INSPECTIONS
FDA / GMP Audit Readiness
Structured preparation for audits and inspections, including evidence review and finding follow-up.
Document gap assessment
Internal and supplier audits
Remediation plans and follow-up
04
CONTINUOUS IMPROVEMENT
CAPA & Quality Investigations
Practical investigations that reach root causes and convert findings into verifiable action.
Deviations and nonconformities
Root cause analysis
CAPA and effectiveness checks
05
DQ · IQ · OQ · PQ
Validation & Qualification
Technical and documentary support to demonstrate that equipment, facilities, systems and processes operate as intended.
Equipment and processes
Water, HVAC and facilities
Calibration and maintenance
06
TRAINING
Training Programs
Remote or in-person courses developed for your team’s actual roles and risks.
GMP, GDP and hygiene
Documentation and quality
CAPA, deviations and Food Safety
SPECIALIZED SERVICES
We can also support specialized needs.
ISO 9001:2015ISO/IEC 17025HACCP · FSMA / HARPCSupplier qualificationSpecificationsRaw materials and traceabilityProduct releaseSupplement label reviewQuality support for new products
WORK PACKAGES
A practical starting point with defined deliverables.
Each package can be tailored after an initial conversation.
01ASSESSMENT
GMP Quick Assessment
A focused review to understand your current state and decide what to address first.
Strategic and operational support for a set number of hours per week or month—ideal for companies that need senior expertise before hiring a full-time manager.
Systems that connect documentation with operations.
Beyond consulting, we design digital solutions and user documentation to organize processes, inventory and follow-up. Our approach comes from hands-on experience in warehouse operations, systems and implementation.
The solution must remain understandable, executable and maintainable after our engagement.
01
Assessment
We learn the process, current documentation, risks and objective.
02
Prioritization
We organize gaps by impact so time and resources focus where they matter.
03
Implementation
We develop the agreed documents, controls, training or solutions.
04
Knowledge transfer
We leave clear instructions and support adoption and follow-up.
COMPLEMENTARY EXPERIENCE · GROWING TEAM
Regulatory quality and operational systems, viewed as one.
Professional Aid Partners LLC combines technical, compliance and field experience to create realistic solutions for small and midsize businesses.
EMS
Eneida Mariela Salazar Martínez
Senior Quality Assurance · Food Safety · Quality Systems
Chemical Process Engineer with more than 16 years leading and strengthening quality systems, manufacturing operations, compliance, laboratory controls, validation and continuous improvement.
FDA, 21 CFR, GMP and GDP
ISO 9001 · ISO/IEC 17025
CAPA, audits, validation and Food Safety
JAS
Jorge A. Salazar
Systems · Inventory · Digital Operations
Systems Engineer experienced in inventory control, warehouse operations, data analysis, technical support, incident documentation and web solution development.
Inventory, WMS, Odoo and traceability
Digital platforms and processes
Documentation, reports and user training
+2
UPCOMING TEAM MEMBERS
Two new professionals will join Professional Aid Partners.
They will expand our technical and bilingual capacity. Their profiles, specialties and credentials will appear here when they officially join.
PRACTICAL INSIGHTS
Ideas to strengthen quality, compliance and operations.
01
Why a regulated business needs quality consulting before an inspection
Early preparation helps identify documentation gaps, assign ownership and turn regulatory requirements into sustainable practices.
Professional transparency. We provide consulting, assessment, preparation, implementation and support. We do not issue certifications, act on behalf of regulators or guarantee approvals or inspection outcomes.
PAP
PROFESSIONAL AID PARTNERS LLC QUALITY · OPERATIONS · TECHNOLOGY
Technical and specialized consulting from Denver for businesses in Colorado and across the United States.