Commitment to Quality

Quality assurance in healthcare is rather a necessity than just a qualification. Thus, corner-stone of our mission is to provide high-quality services to our clients, aiming to meet their needs and most demanding expectations.

How we achieve it

To have this mission accomplished, our company developed a quality culture, embedded into all aspects of business operations, from the implementation and maintenance of a Quality Management System (QMS), the continuous monitoring of legislation and regulatory updates, to the compliance with business ethics and the development of practices ensuring financial sustainability and social responsibility.

But our commitment to quality goes beyond the delivery of high-quality services. It also focuses on meeting our endeavors for continuous improvement of our systems, processes, operating procedures and standards. This is our Quality Assurance (QA) team’s responsibility: to monitor our Quality Management System’s effectiveness and, through regular quality controls and audits, identify any process or practice that could keep us away from excellence!

How can we prove our committment?

As a token of our commitment to quality, we have been awarded with ISO 9001:2015 certification, which extends to all divisions and functions of the company and ensures that all company’s activities are carried out to the highest technical, scientific and professional standards in full adherence to:

• Local, national and international legislation
• ICH Guidelines and Principles
• Ethical, legal and regulatory standards
• Standard Operating Procedures
• ISO 9001:2015 Requirement

ISO Quality Certification

Our company has been certified to the EN ISO 9001 International Quality Standard since 2004, representing the Company’s never-ending commitment to continuous improvement and provision of high-quality services and solutions.

The present certificate states that the Quality Management System of the Company (including all processes) meets the requirements of the new International Standard ISO 9001:2015 with the following scope:

Provision of Services for Clinical Study Design and Conduct to International and local Pharmaceutical, Biotechnology and Medical Device Industries, as well as Pharmacovigilance, Clinical Data Management and Statistical Analysis, Medical Writing, Regulatory Affairs, Patient Support Programs, Training, Consulting Services in Healthcare Sector and Medical Information Management.