01 / OPERATIONS
GMP Shop Floor QA Oversight
On-floor Quality presence, manufacturing observations/corrections/path forward, batch record review, issue escalation, and risk-based GMP decision-making.
Independent pharmaceutical & biotechnology quality consulting
Quality that stands up to scrutiny.
Practical, risk-based GMP Quality solutions for complex manufacturing environments—from the production floor to the inspection room.
A
INTEGRITY · COMPLIANCE · EXCELLENCEGMP QUALITY OPERATIONS & REGULATORY READINESS
30+ YearsQuality Assurance and Quality Control experience
18 YearsQuality Operations oversight
5 StartupsManufacturing startup experience
4 PAIsPre-approval inspections supported
Our expertise
Focused solutions for critical Quality challenges.
Asevera provides hands-on support and experienced Quality leadership tailored to each facility's manufacturing operations, compliance priorities, and business needs.
02 / ASEPTIC
Sterile & Aseptic Manufacturing
Quality oversight for aseptic operations, sterile fill-finish, contamination control strategy, aseptic process simulation, and manufacturing readiness.
03 / SYSTEMS
QMS & Compliance Remediation
Deviation/Nonconformace and investigation programs, root cause analysis, CAPA, change control, documentation, and effectiveness checks.
04 / INSPECTIONS
Inspection Readiness
Mock inspections, gap assessments, inspection preparation, regulatory observation remediation, and inspection response support.
05 / RELEASE
Batch Review & Disposition
Batch record review, batch release process improvements, and product disposition governance.
06 / LEADERSHIP
Interim Quality Leadership
Interim Quality Operations leadership, team coaching, startup support, Quality organization stabilization, and continuous improvement.
The Asevera approach
A.
Independent judgment. Practical execution.
Quality decisions grounded in science, regulatory expectations, and patient safety.
Leadership & experience
Senior expertise. Hands-on commitment.
Asevera GMP & Quality Consulting LLC is led by Nelida Reyes Laboy, a pharmaceutical Quality leader with more than three decades of experience across biologics, sterile injectables, cell and gene therapy, and compounding operations.
Her experience includes active GMP manufacturing-floor oversight at Amgen, Boehringer Ingelheim, Shire, and Charles River Laboratories, as well as Quality Systems leadership, regulatory inspection support, and direct product disposition authority.
At Charles River Laboratories, she led a QA Operations organization supporting autologous and allogeneic cell therapy programs.
GMP Quality Operations
Aseptic Manufacturing
FDA Inspection Readiness
Quality Risk Management
Deviation & CAPA
Interim Quality Leadership
Industries served
Experience across diverse GMP environments.
Engagements can be structured for onsite, hybrid, or remote support based on project needs and scope.
Pharmaceutical ManufacturingClinical and commercial GMP operations
Biotechnology & BiologicsMammalian and microbial platforms
Cell & Gene TherapyAutologous and allogeneic programs
Sterile & CompoundingAseptic processing and fill-finish
Your Quality partner
Facing a complex GMP challenge?
Let's discuss the right level of Quality support for your operation.
Get in touch
Let's talk about your Quality priorities.
Contact Asevera to discuss GMP shop floor coverage, Quality Systems remediation, inspection readiness, or interim Quality leadership.
BusinessAsevera GMP & Quality Consulting LLC
Business address6222 E Pine Lane
Suite 6212 #1114
Parker, CO 80138
Suite 6212 #1114
Parker, CO 80138
AvailabilityAvailable for project-based travel
Phone720-580-3252
Emailinfo@aseveragmp.com