Quality Plus

What Quality Plus does

Quality Plus is a privately-held, São Paulo-headquartered independent consultancy specializing in Good Clinical Practice (GCP) auditing and quality assurance for the clinical trials industry. Founded in 2009, the firm serves clinical trial sponsors, contract research organizations, and research sites requiring regulatory inspection readiness across North America, Central America, and South America, with additional reach into South Africa. Its portfolio covers five core service lines: Quality Management Systems (QMS) evaluation, setup, and implementation; Regulatory Compliance Auditing against FDA, EU, and ICH guidelines; Site Audits for Human Medicine (Phase I-IV); Site Audits for Veterinary Medicine under VICH GL9; and a set of audit types including Sponsor Internal Audits, Vendor/CRO Qualification Audits, On-Site Audits, Inspection Readiness Reviews, Phase I Facility Audits, and Mock Audits/Self Inspections. The firm is ISO 9001 certified and its auditors are registered with the Society of Quality Assurance (RQAP), with trilingual delivery capability in English, Spanish, and Portuguese.

Each engagement follows a structured methodology — pre-meeting calls, preparation, on-site activities, reporting, debrief meetings, and audit certification — executed under documented Standard Operating Procedures, Working Instructions, and Specific Forms. Quality Plus differentiates on independence (auditors are not associated with sponsors, CROs, or other interested parties), deep regional regulatory knowledge, and multilingual coverage that eliminates translation friction for cross-border sponsors. The firm has completed 145 audits across 10 countries/regions, with Brazil (66) and Argentina (24) representing the largest concentrations, followed by Mexico (11), USA/Puerto Rico (11), Panama/Nicaragua/Dominican Republic (9), Peru (8), Chile (7), Colombia (7), and South Africa (2).

Quality Plus operates a sales-led, direct-engagement go-to-market with 19 employees, no disclosed funding, no parent company, and no public pricing. Revenue is generated through professional services fees for audits, QMS work, compliance advisory, and ancillary deliverables. The firm appears to be founder-owned or managed by senior QA professionals and competes against Big Four advisory practices, specialized clinical QA consultancies, and in-house sponsor audit teams in the Latin American clinical trials market.

Name

Quality Plus

Legal name

Quality Plus

Website

https://qualityplus.com.br

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Quality Plus is a São Paulo-based independent consultancy providing Good Clinical Practice (GCP) auditing, Quality Management Systems implementation, and regulatory compliance services to clinical trial sponsors, CROs, and research sites across the Americas and South Africa.

Ownership category

akta.pro rank

Product category

GCP Auditing and Clinical Trial Compliance Services

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Site Quality Management & Audit Readiness (HLAGACAN)

Keywords

• GCP auditing services
• Clinical trial compliance
• Quality management systems
• Regulatory compliance auditing
• Clinical trial site audits

Headquarters

HQ city

São Paulo

HQ country

Brazil

HQ region

Latin America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Professional Auditing Services: Quality Plus generates revenue through providing independent auditing and consultancy services for clinical trials, including site audits, regulatory compliance assessments, and quality management system evaluations. Services include pre-audit preparation, on-site auditing, reporting, and certification.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Quality Plus is an independent consultancy providing Good Clinical Practice (GCP) auditing, quality assurance, and regulatory compliance services for clinical trials. The firm conducts site audits for human and veterinary medicine, vendor/CRO qualification audits, inspection readiness reviews, and evaluation, setup, and implementation of quality management systems for clinical trial sponsors, pharmaceutical companies, and research sites across the Americas.

Product overview

Quality Plus is an independent GCP (Good Clinical Practice) auditing consultancy providing a unified portfolio of compliance and quality assurance services. The core offerings include Quality Management Systems (QMS) evaluation and implementation, Regulatory Compliance Auditing (FDA/EU/ICH), Site Audits for Human Medicine (Phase I-IV), Site Audits for Veterinary Medicine (VICH GL9), and various audit types (Sponsor Internal Audits, CRO Qualification Audits, On-Site Audits, Inspection Readiness Reviews, Phase I Facility Audits, and Mock Audits). All services are delivered by senior multilingual auditors following company Standard Operating Procedures, with each site audit comprising pre-meeting calls, preparation, on-site activities, reporting, debrief meetings, and audit certification.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Management Systems (QMS) Evaluation, review, setup, and implementation of quality management systems in organizations, including document review for SOPs, clinical GCP protocols, reports, and system audits. Also covers audits of submissions for ethical approval, facility inspections, and critical phase inspections of clinical studies. Aimed at clinical trial sponsors and research organizations requiring robust QMS frameworks.
• Site Audits - Human Medicine GCP audits of clinical trials in humans covering Phase I-IV facilities, including Investigator Site Audits and Vendor Audits for qualification and requalification. Designed for pharmaceutical sponsors, biotech firms, and research sites operating human clinical trials in the Americas.
• Site Audits - Veterinary Medicine Audits of clinical studies for veterinary medicinal products (VMP) in target species, ensuring compliance with VICH GL9 Good Clinical Practices guidelines. Facilitates mutual acceptance of clinical data by regulatory authorities in VICH regions. Aimed at sponsors and sites conducting veterinary clinical studies.
• Regulatory Compliance Auditing Assessment of compliance with FDA/EU regulations and ICH guidelines to ensure organizations meet all necessary regulatory requirements for clinical trials. Aimed at pharmaceutical sponsors, biotech firms, and clinical research organizations operating in regulated markets.
• Quality & Compliance Advisory Proactive compliance management including establishing robust processes, conducting internal audits, implementing corrective actions, and proper documentation of written policies and procedures. Designed for clinical trial sponsors and researchers seeking to identify and mitigate compliance gaps before regulatory inspections.
• Types of Audits Comprehensive audit services including Sponsor Internal Audits, Vendor/CRO Qualification Audits, On-Site Audits, Inspection Readiness Reviews, Phase I Facility Audits, and Clinical Trial Sponsor Mock Audits/Self Inspections. Aimed at clinical trial sponsors, CROs, and Phase I facilities requiring qualification and compliance monitoring.

Quantifiable outcome

• Reduces emissions by eliminating need for intercontinental flights through regional auditor coverage

Segments3 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Maetrics: Maetrics provides GxP compliance consulting, quality system implementation, and audit services for life sciences companies, overlapping closely with Quality Plus's QMS and regulatory compliance offerings.
• RQM+: RQM+ is a specialist GCP/GLP/GMP quality and regulatory consulting firm offering independent audits, QMS implementation, and inspection readiness — directly comparable to Quality Plus's core service portfolio but operating primarily in the U.S. and EU.
• Claigan Environmental & Quality Services: Claigan provides regulatory and quality auditing services for life sciences companies including GCP audits, supplier qualification, and inspection readiness — closely aligned with Quality Plus's service mix.
• Auropa: Auropa is an independent GxP auditing and consulting firm covering GMP, GCP, GLP and pharmacovigilance audits — directly comparable services targeting pharma and biotech sponsors in Europe and beyond.
• QRC Group (Quality, Risk & Compliance): QRC Group is a quality and compliance consultancy offering GCP audits, vendor qualification, and QMS services to pharma and biotech sponsors — a direct competitor in independent clinical quality assurance.

Broad incumbents

• IQVIA: IQVIA is the world's largest CRO offering clinical quality assurance and audit services as part of a broad portfolio of clinical, technology, and consulting services.
• ICON plc: ICON is a major global CRO providing quality assurance, GCP auditing, and regulatory compliance services alongside its full clinical development portfolio.
• Parexel International (part of EQT/Goldman Sachs): Parexel is a global CRO offering comprehensive clinical trial services including quality assurance and GCP audits as part of its wider portfolio, competing with Quality Plus for sponsor compliance budgets.
• PSI CRO: PSI CRO is a mid-sized global CRO with strong presence in Eastern Europe and Latin America, offering clinical trial services and quality/compliance audits comparable in scope to Quality Plus's offerings.

Regional players

• Bioagri (Brazil): Bioagri is a Brazil-based CRO offering clinical research services across Latin America, with overlapping quality assurance capabilities and competing in Quality Plus's home market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/quality-plus-clinicals

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Quality Plus