Caraballo Consulting & Associates

What Caraballo Consulting & Associates does

Caraballo Consulting & Associates, LLC is a privately-held professional services firm founded in 2015 and headquartered in Doral, Florida. The company delivers regulatory, clinical, quality assurance, manufacturing, engineering, and audit consulting services to clients in the Medical Device, Pharmaceutical, and Biotechnology industries. Its stated team comprises subject matter experts across Regulatory Compliance and Submissions, Clinical, Quality Assurance, Manufacturing, Black Belt, Lean Manufacturing, Engineering, and Specialized Engineering disciplines, with the firm's website (caraballoconsulting.com) functioning as its primary digital presence.

The firm's service portfolio includes Regulatory Compliance and Submissions Consulting, Clinical Consulting, Quality Assurance Consulting, Manufacturing Consulting (incorporating Lean methodologies), Engineering Services, and Audit Services. The firm is intentionally technology-light: there is no proprietary software platform, no app, no API, no disclosed technology stack, and no AI/ML capabilities. All service delivery is built on human expertise delivered through project-based engagements, with the firm explicitly emphasizing a collaborative approach that pairs the "right level of expertise" to each client's scope.

Revenue is generated through professional services engagements, with custom-quoted project fees and retainer arrangements for clients in regulated industries. Go-to-market is sales-led, driven by a Director of New Business Development conducting direct phone and email outreach. The firm serves the US market exclusively from its Doral base, operates without disclosed intermediaries, has no parent company, has raised no external funding, and lists no partnerships, awards, certifications, or patents.

Name

Caraballo Consulting & Associates

Legal name

CARABALLO CONSULTING & ASSOCIATES, LLC

Website

https://caraballoconsulting.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Caraballo Consulting & Associates is a Doral, Florida-based consulting firm founded in 2015 that delivers regulatory compliance, clinical, quality assurance, manufacturing, engineering, and audit advisory services to Medical Device, Pharmaceutical, and Biotechnology clients across the United States.

Ownership category

akta.pro rank

Product category

Regulatory & Quality Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169), Other Management Consulting Services (541618)

SIC

Services-Management Consulting Services (8742), Services-Engineering Services (8711)

akta.pro primary industry

Industrial & Process Engineering Consulting (BPAHAIAF)

akta.pro secondary industry

Data, Analytics & AI Consulting (BPAHAEAF)

Keywords

• Regulatory compliance consulting
• Quality assurance services
• Medical device consulting
• Pharmaceutical consulting
• Biotechnology consulting

Headquarters

HQ city

Doral

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Consulting Services Revenue: Professional consulting engagements providing customized solutions in regulatory compliance, submissions, clinical services, quality assurance, manufacturing consulting, and specialized engineering. Revenue generated through project-based consulting fees and retainer arrangements with clients in regulated industries.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Caraballo Consulting & Associates provides specialized consulting services in regulatory compliance and submissions, clinical, quality assurance, manufacturing (including Lean Manufacturing), engineering, and audit services. Its consultants operate as subject matter experts supporting Medical Device, Pharmaceutical, and Biotechnology clients through customized project-based and retainer engagements.

Product overview

Caraballo Consulting & Associates is a consulting firm offering a portfolio of specialized consulting services primarily serving the Medical Device, Pharmaceutical, and Biotechnology industries. The company provides a unified suite of services including Regulatory Compliance and Submissions, Clinical Consulting, Quality Assurance, Manufacturing Consulting (with Black Belt and Lean Manufacturing methodologies), Engineering Services, and Audit Services. These offerings are designed to work collaboratively to deliver comprehensive consulting solutions that help clients achieve their business goals through customized, cost-effective approaches.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Compliance and Submissions Consulting Expert consulting services to help clients navigate regulatory requirements and prepare submissions for Medical Device, Pharmaceutical, and Biotechnology industries.
• Clinical Consulting Services Subject matter expertise in clinical domains to support product development and regulatory compliance for life sciences companies.
• Quality Assurance Consulting Consulting services focused on quality assurance processes and systems for medical device, pharmaceutical, and biotechnology organizations.
• Manufacturing Consulting Expert guidance on manufacturing processes including Lean Manufacturing methodologies to optimize production efficiency.
• Engineering Services Engineering and Specialized Engineering consulting services to support product development and manufacturing operations.
• Audit Services Professional audit services for regulatory compliance verification and quality system assessments.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Recent moves4 records

Expansion highlights3 records

Direct peers

• Maetrics: Life sciences compliance, quality, and regulatory consulting firm with explicit focus on medical devices and pharmaceuticals. Directly comparable peer in service mix and target verticals.
• The FDA Group: Specialized regulatory, quality, and compliance consulting firm serving medical device, pharma, and biotech clients. Closely comparable to Caraballo in life-sciences regulatory focus, though it operates at meaningfully greater scale.
• Quality and Regulatory Associates (QRA): Medical device and pharma-focused regulatory and quality systems consulting firm. Mid-sized peer offering closely overlapping services in regulatory submissions, QA, and compliance to the same verticals.
• RQM+ (RQM+ formerly known as MDI Consultants): Medical device regulatory and quality consulting firm providing submissions, clinical, and post-market services. Directly comparable boutique-style peer with overlapping service lines.

Broad incumbents

• NAMSA: Largest medical-device-focused CRO and consulting organization, covering regulatory, quality, clinical, and laboratory services. A broader incumbent that competes for many of the same medical-device compliance and submissions engagements Caraballo targets.
• Parexel International: Global CRO with substantial regulatory, clinical, and consulting capabilities for pharma and biotech. A broad incumbent that competes at the upper end of the same addressable market Caraballo serves.
• NSF (Health Sciences): Global consulting and certification provider with deep medical device, pharma, and biotech regulatory and quality practices. A broad incumbent offering regulatory, quality, and engineering advisory overlapping directly with Caraballo's service portfolio.
• BSI Group: Standards, certification, and consulting firm with significant medical device regulatory and quality systems practice. Broad incumbent that overlaps on audit, regulatory, and QA services Caraballo delivers.

Emerging players

• Sterling Pharma Services: Pharmaceutical contract development and consulting organization with adjacent GMP and regulatory expertise. Looser peer, but overlapping on pharma regulatory and manufacturing compliance.
• Compliance Insight: Boutique life-sciences regulatory and quality compliance consultancy serving pharmaceutical and medical device companies. Small peer with comparable service profile and target client base.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat2 records

Key risks5 records

Key highlights5 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

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 Caraballo Consulting & Associates