Gsap Family Accelerates The Development And Verify That Safe And Effective Advanced Products Are Available To Everyone.

Since 2009, Gsap Family Is A Leading Partner In The Biomed Industry. Our Level Of Expertise, Values, And Reputation Ensure The Enhancement Of Companies In The Industry: Pharmaceuticals, Advanced Therapies, Medical Devices, Digital Health, Hospitals, And Food Tech Throughout The Life Cycle Of The Products.

Gsap Is An International Consulting Firm For Healthcare Companies, Providing End-To-End Services Throughout The Life Cycle Of Medical Products.

Gsap Aspires To Enhance The Development And Maturation Of Healthcare Companies And To Empower Them To Achieve Significant Therapeutic Solutions For Patients Worldwide.

Over The Years, Gsap Has Developed Methodologies To Combine Many Departments And Disciplines In The Implementation Process Of Quality While Creating Significant Cooperation Experience For All Participants In The Process: Employees And Managers In Production Plants, Start-Ups, Contractors, Suppliers, And Consultants. Gsap’s Staff Has Broad Education And Many Years Of Experience In The Relevant Industries, Which Enables Taking Extensive Responsibility For The Services Provided To Clients And Their Outcomes, Creating Cooperative Work, And Achieving Integrative Impact. Since 2009, Gsap Has Served Hundreds Of Clients, From Start-Ups To Large International Companies.

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Almond Is A Professional, Cloud-Based, Quality Management Software For Healthcare Companies.

The Software Enables Computerized Management Of The Quality Processes In Compliance With Regulatory Requirements (21 CFR Part 11, ISO 13485:2016 And 21 CFR Part 820). The System Maintains A Document Audit Trail, Full Document Indexing, And Ultimately Achieves Documented Evidence Of All QMS Processes.

Almond Was Established After Many Years Of Consulting And Accompanying The Quality Process For Numerous Health Care Companies With Gsap®. The Software Allows The Proper Management Of Resources And Documents And An Unlimited Number Of Users Can Use It Simultaneously. One Can Save Or Distribute A Wide Variety Of Documents, Regardless Of Their Sizes, And Manage Documents Using Workflows That Are Tailored To Customer Requirements.

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SE Pharma Provides Validation And Calibration Services Along The Supply Chain Of Pharmaceuticals And Medical Devices.

The Company Is Certified For Calibration According To ISO / IEC 17025: 2017 By The National Authority For Laboratory Accreditation. The Company Brings A Refreshing Line To The Calibration Labs Market In Terms Of Professional Quality And Service Issues. Pharmaceutical Companies, Trading Houses, Distributors, And End Customers Enjoy The Highest Level Of Professional Service.

We Offer Validation Services For Equipment And Refrigerators, Validation For Transport Vehicles And Temperature And Humidity Controlled Warehouses, Temperature Calibration, Pressure, Humidity, Mass, Conductivity, PH, And RPM. The Company’s Employees Have Extensive Knowledge And Proven Experience In The Fields Of Validation, Calibration, Equipment Certification, And Quality Assurance, Thus Providing A Comprehensive And Ideal Solution To Customers From The Medical World.

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Innovative Center For Training And Learning For Pharma, Advanced Therapies, Medical Devices, And Medical Cannabis Industries.

The Center Is Based On Knowledge Sharing And Transfers The Professional Knowledge Gained From Our Best Experts. Our Goal Is To Promote And Improve Professional Excellence In Employees In The Medical Industry In The State Of Israel.

Study Offers A Variety Of Courses In Different Fields And Industries: Communities And Forums-Experts That Provide A Platform For Fulfilling And Shared Learning Between Colleagues From The Same Field. Courses And Seminars-Professional Courses And Seminars In A Variety Of Fields Provide Theoretical And Practical Knowledge. Webinars-Professional Webinars Delivered By Gsap Experts, Covering A Variety Of Topics In The Healthcare Industry

Internal Organizational Training-Tutorials, Workshops, And Seminars Specifically Tailored To The Client’s Request And Needs.

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GSAP GROUP HISTORY

2009

Gsap was founded by Sigalit Ariely-Portnoy, PhD, to provide quality and validation services to the pharmaceutical industry

2011

Gsap leaded Israel Chemicals Ltd receive IMOH & FDA GMP certification for the first time

2012

Pluristem, our first cell therapy client used Gsap’s expertise for quality and validation of its new facility in Haifa
Since then, 40 Advanced Cell Therapy companies from Israel and the US have used Gsap expertise

2014

Gsap established its medical device department by hiring the best regulatory, quality and validation experts
Since then, Gsap has worked with more than 500 medical device companies

2015

Philips remediation plan and execution was led successfully by 15 experts from Gsap

2016

SE-Pharma, Gsap’s affiliate was founded to support Gsap clients implement GDP and IMOH SOP 126. The company is certified for ISO 17025
The first CAR-T cell therapy product was submitted to the IMOH on behalf of the Ella Institute at Sheba Medical Center, with Gsap’s support and guidance. To date, 160 children and adults with leukemia were successfully treated

2017

At the behest of clients, Gsap established its clinical department with experts from international CROs
This department functions as a boutique CRO for clinical trials execution, operating according to ICH-GCP standards

2018

Almond, Gsap’s affiliate was founded in order to provide a world class electronic Quality Management System (QMS) for biomed companies according to 21 CFR part 11 and data integrity regulations.
Gsap was divided into sections, creating an organization that would support hundreds of clients, from small to large-scale projects, at the same time

2019

Gsap supported the development of more than 20 medical cannabis farms and manufacturing plants: from design to validation, establishing robust quality systems and bringing IMC-GAP, GACP, IMC-GMP, IMC-GDP and EU-GMP certification to Israeli companies
Gsap celebrated its 10 year anniversary!

2020

G-study was founded to create innovative learning methods for the future
Gsap led and expedited COVID -19 vaccine development, regulatory submission and clinical testing of IIBR’s new vaccine, in Israel
Gsap has submitted COVID-19 IVD, inhalers, and special safety devices for regulatory approval according to specific accelerated pathways, worldwide
Gsap is one of the leading CROs for COVID-19 clinical trials in Israel
Gsap promotes the professional character of emerging fields, with recruitment of new experts in novel food (foodtech) and digital health

2021

Gsap supported the development of more than 10 Digital health and AI companies (SaMD): from development to validation, establishing robust quality systems and submission of these solutions to the FDA.
Gsap lead IVD and personalized medicine companies to define their regulatory pathway and document their development according to the new regulation in Europe (IVDR) and the requirements of the FDA.
Gsap helped (and continue) to medical device companies to renew their CE license according to the MDR.
Gsap clinical section continues to grow and give end2end services to phase 2b multi-center, double-blind, placebo controlled trial, and support Israeli companies in the management of phase 3 trials around the world. The department also support medical device, IVD and digital health clinical trials.