WHO WE ARE

Our History

GB Pharma is an established and innovative CRO which, operating in a constantly changing environment, has grown over the years.

1999
Foundation of GB Pharma

17 NOVEMBER 1999

Foundation as a Full service CRO for conduction of Clinical Trials

2006
Introduction of Pharmacovigilance and Regulatory Affairs service

Expanding the company's portfolio to ensure continuous drug safety monitoring and full regulatory compliance throughout the entire product life cycle

2015
Introduction og the services of QPPV role

according to the European Union's Commission Regulation (EU) 2022/510

With over 25 years of experience, GB Pharma offers customized clinical solutions, regulatory support and pharmacovigilance by modulating services based on the needs of the Customers.

WHY CHOOSE US

Our Mission

Expert Support for Pharmaceuticals, Biotech, Medical Devices & More

We support pharmaceutical, biotech, medical device, supplement, and cosmetic companies, as well as IRCCS and Scientific Foundations, in ensuring safety, quality, and efficacy. Our team delivers highly qualified services in regulatory affairs, clinical research, pharmacovigilance, and quality assurance, tailored to meet the specific needs of every project. Through a proactive and compliant approach, we help organizations navigate the complex regulatory landscape, accelerate product development, and maintain full compliance with national and international standards.

DEDICATED AND EFFICIENT STRUCTURE

A dynamic, results-oriented organization delivering high-quality regulatory affairs, clinical research, and pharmacovigilance services with optimized costs. GB Pharma offers flexible and sustainable solutions tailored to meet every project need in the pharmaceutical and medical device sectors.

PROACTIVE AND CUSTOMIZED APPROACH

We design strategic regulatory and clinical solutions and develop personalized pathways to achieve objectives with speed and efficiency. Our team supports the entire lifecycle — from clinical trials to marketing authorization — ensuring a smooth regulatory process.

OPERATIONAL EXCELLENCE AND CERTIFIED QUALITY

We operate according to strict national and international standards, following certified procedures (GxP, ISO 13485) to guarantee accuracy, reliability, and full regulatory compliance at every project stage. Our expertise covers drug development, medical device classification, and post-marketing pharmacovigilance.

CONSTANT PRESENCE AND DIRECT SUPPORT

Our management team is always by your side, ensuring continuous, timely, and expert interaction. We provide direct support throughout all phases of regulatory projects, from clinical study design to submission documentation, building long-term partnerships based on trust and scientific excellence.

OUR MODEL

How we work

GB Pharma’s Approach: Excellence Without Compromise

Our focus is on maintaining the highest quality standards — from regulatory documentation to clinical trial management — while reducing project timelines and, most importantly, optimizing costs.
Through innovative methodologies and a proactive, customized approach, we ensure that every stage of the project — from development strategy to marketing authorization — is handled with precision, compliance, and efficiency.