Gsap

What Gsap does

Gsap is an Israeli professional services consulting firm headquartered in Haifa, founded in 2009, that provides end-to-end regulatory, quality, clinical, and engineering services to biomedical and life-science companies across seven industry verticals: medical devices, pharmaceuticals and biotechnology, advanced therapies (cell and gene), medical cannabis, digital health, food tech, and hospitals. The firm delivers regulatory strategy and submissions to FDA, EMA, and the Israeli Ministry of Health; quality management system setup and audit preparation; Contract Research Organization (CRO) services for Phase I-II clinical trials; engineering validation and qualification (IQ/OQ/PQ); and computerized systems validation (CSV). Core service lines are organized around recognized frameworks including GxP, GEP, GMP, ISO 13485, MDSAP, IEC 62304, ICH-GCP, and ISO 14155.

The business operates through four wholly-owned subsidiaries that extend its offering beyond consulting hours: SE-Pharma (GDP compliance and ISO/IEC 17025:2017 accredited laboratory services, est. 2016), Gsap CRO (boutique Phase I-II clinical trial management, est. 2017), Almond (electronic Quality Management System software platform, est. 2018), and G-Study (professional training, auditor certification, and the PractiClean conference, est. 2020). Revenue is generated through project-based professional services engagements, training course fees, and the Almond QMS software product, sold via direct consultative sales to enterprise clients including startups, pharma companies, hospitals, and medical device manufacturers. The firm employs approximately 60 staff at the parent plus 15 across subsidiaries, and reports cumulative engagement of 2,000+ projects, 300+ medical device clients (since 2014), and 40+ advanced therapy clients (since 2012), with notable customer engagements including Johnson & Johnson's Biosense Webster, Philips Haifa, Pluristem, Sheba Medical Center, Hadassah Medical Center, the Israel Institute for Biological Research (IIBR), and Syqe Medical.

Gsap is privately held with no external funding rounds disclosed and operates under a management-owned structure following the founding-era transition from founder Dr. Sigalit Ariely-Portnoy to current CEO Sharon Alon. Distribution is primarily direct enterprise sales complemented by content marketing, webinars, the PractiClean conference, and the Gstudy training platform, with geographic reach spanning the US, Europe (Germany, Netherlands), and the broader Israeli biomedical ecosystem.

Name

Gsap

Legal name

Gsap

Website

https://gsap.co.il

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

51–100 employees

Short description

Gsap is an Israeli biomedical consulting firm providing regulatory affairs, quality assurance, CRO clinical research, engineering validation, and electronic QMS software to medical device, pharma, advanced therapy, digital health, medical cannabis, food tech, and hospital clients globally.

Ownership category

akta.pro rank

Product category

Biomedical Regulatory & Quality Consulting

NAICS

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

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industries

Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM), CMC, Process Development & Tech Transfer Staffing FSP (HLAGAOAK)

Keywords

• Regulatory affairs consulting
• Quality assurance services
• Biomedical consulting
• GMP compliance consulting
• Clinical research services

Headquarters

HQ city

Haifa

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs & Quality Consulting: Gsap charges fees for regulatory strategy, submissions (FDA, EMA, IMOH), quality management system setup, and compliance consulting. Revenue is project-based and varies by scope, typically structured as professional services engagements.
2. CRO — Clinical Research Services: Full-service clinical trial management including study design, site management, monitoring, data management, biostatistics, and clinical study reports. Revenue is generated through project fees and service contracts following ICH-GCP standards.
3. Gstudy — Professional Training Courses: Gsap operates Gstudy, a training center offering professional courses, seminars, auditor certification programs, and webinars. Revenue is generated through course fees.
4. Engineering & Validation Services: Charges for engineering validation, qualification (IQ/OQ/PQ), facility design review, and GMP compliance services for pharmaceutical and medical device manufacturing facilities.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

Gsap is a professional consulting firm providing end-to-end biomedical services spanning the entire product lifecycle — from concept to market — for pharmaceutical, medical device, advanced therapy, digital health, food tech, medical cannabis, and hospital clients. Core service lines include regulatory affairs (FDA, EMA, IMOH submissions), quality assurance and QMS setup, clinical research (CRO) trial management, engineering validation (GEP/GMP), computerized systems validation (CSV), pre-clinical studies, audit preparation, and grant writing. The firm supplements consulting with its Gstudy training academy and Almond electronic QMS platform, all delivered by 50+ expert consultants from its Haifa, Israel headquarters.

Product overview

Gsap is a comprehensive consulting and services firm for the biomedical industry, providing end-to-end services across the product lifecycle. The portfolio consists of core consulting service lines — Regulatory Affairs, Quality Assurance (QMS), Clinical Research (CRO), Engineering & Validation, Computerized System Validation (CSV), Pre-Clinical Studies, Grant & Technical Writing, and Audit Preparation — organized by specialized industry verticals: Pharmaceuticals, Medical Devices, Digital Health, Advanced Therapies (ATMP), FoodTech, Medical Cannabis, and Hospitals. The company operates two named sub-brands: Gsap CRO (a boutique CRO for clinical trial management under ICH-GCP) and Gstudy (a professional training and education center). Gsap's services are not packaged as a single software product but as professional consulting engagements delivered by domain experts.

Differentiator

Problem solved

Functional benefit

Brands

• G-Study (Gstudy): Training and learning center offering professional courses, seminars, auditor certification, internal organizational training, online courses, and webinars for the pharma, advanced therapies, medical devices, and medical cannabis industries.
• Gsap CRO
• Almond
• SE-Pharma

Products and services

• Regulatory Affairs Consulting End-to-end regulatory strategy and submission services for biomedical products targeting FDA, EMA, Israeli Ministry of Health (IMOH/AMAR), Health Canada, and TGA, covering pre-IND/IND, NDA, BLA, MAA, 510(k), CE marking, and ATMP regulatory pathways for pharma, medical device, advanced therapy, digital health, food tech, and medical cannabis clients.
• Quality Assurance (QMS) Consulting
• Gsap CRO - Clinical Research Services Full-service Contract Research Organization providing clinical trial management from study design, regulatory submissions, site selection, monitoring, data management, biostatistics, and clinical study reports, following ISO 14155 and ICH-GCP standards for medical device, pharmaceutical, and advanced therapy trials.
• Engineering & Validation Services
• Computerized Systems Validation (CSV)
• Pre-Clinical Studies
• Audit Preparation & Inspection Support
• Grant & Technical Writing
• Gstudy - Professional Training Programs Professional training center offering courses, seminars, auditor certification programs, and webinars for pharma, medical device, advanced therapy, and medical cannabis industries. Courses are delivered both in-person at the Haifa training center and online in hybrid format; in-house corporate training programs are also available.
• Almond - Electronic Quality Management System (QMS) Electronic Quality Management System (QMS) software platform (Almond II being the next-generation product) for biomedical companies, supporting document control, CAPA management, complaint handling, and quality process workflows.
• SE-Pharma - GDP Compliance Services Good Distribution Practice (GDP) compliance consulting, Ministry of Health Procedure 126 implementation, and ISO/IEC 17025:2017 accredited laboratory services for pharmaceutical distributors and biomedical companies.

Quantifiable outcome

• 2000+ projects completed across biomedical consulting portfolio
• +5 more outcomes

Named customers13 records

Segments7 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature5 records

Partnerships

Four partnerships are on record, tiered core.

• SE-PharmacoreOthersSE-Pharma is a wholly-owned subsidiary of Gsap, established in 2016 to support Gsap clients in implementing GDP requirements and Israeli Ministry of Health Procedure 126. The company is accredited to ISO/IEC 17025:2017 standards.
• Almond (electronic QMS)coreOthersAlmond is a wholly-owned subsidiary of Gsap, established in 2018 to provide an electronic Quality Management System (QMS) at world-class level to biomedical companies in Israel and globally. Almond II represents the next-generation QMS platform.
• G-StudycoreOthersG-Study is a wholly-owned subsidiary established in 2020 to develop innovative learning methods in the biomedical field. It operates a professional training center offering courses, seminars, webinars, and auditor certification programs for pharma, medical device, advanced therapy, and medical cannabis industries.
• CRO Industry NetworkscoreStrategic or Co-development PartnerGsap CRO was established in 2017 with experts from international CROs to help clients navigate Phase I and Phase II clinical trials. The CRO operates as a boutique CRO for clinical trial execution following ICH-GCP standards.

Scale indicators9 records

Recent moves10 records

Expansion highlights6 records

Direct peers

• QbD Group: Life-science consulting firm specializing in quality assurance, validation, CSV, and regulatory affairs. Closely comparable to Gsap's engineering/validation and CSV service lines.
• BlueReg: European regulatory affairs consulting firm for pharma, biotech, and medical devices. Comparable to Gsap in regulatory strategy and submission services across multiple jurisdictions.
• MakroCare: Clinical research and regulatory services provider spanning pharma, biologics, and medical devices. Comparable to Gsap's combined CRO and regulatory affairs service offering.
• ProductLife Group: International regulatory, compliance, and clinical services consultancy for life sciences. Comparable to Gsap in providing multi-vertical regulatory and quality support to pharma and medtech clients.
• ProPharma Group: Regulatory, compliance, and quality consulting firm serving pharma, medical device, and biotech clients. Directly comparable to Gsap in regulatory submissions, QMS implementation, and CSV/GxP IT services.
• PharmaLex: Global regulatory affairs and quality compliance consulting firm for pharma, biotech, and medical device companies. Highly comparable to Gsap across regulatory strategy, QMS setup, and GxP compliance service lines.

Broad incumbents

• Charles River Laboratories: Global CRO and pre-clinical services provider. Overlaps with Gsap's pre-clinical and clinical research capabilities for biomedical clients.
• ICON plc: Major global CRO providing clinical research and consulting services across pharma and biotech. Overlaps with Gsap's CRO division and broader regulatory advisory work.
• IQVIA: Largest global CRO and life-sciences consulting firm. Competes with Gsap for clinical trial and regulatory consulting work but operates at a vastly larger scale across all major geographies.
• Veeva Systems: Cloud software provider for life sciences including QMS, regulatory, and clinical platforms. Adjacent competitor to Gsap's Almond eQMS and CSV service lines, though at vastly larger scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/gsap-consulting

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries4 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 Gsap