GRALC Quality Commitment

Our Quality Commitment

Quality is integral part of GLOBAL REGULATORY AFFAIRS, LABELING & COMPLIANCE SERVICES, LLC (GRALC LLC)’s Business Principles. These principles guide our actions to deliver high quality and reliable services to our customers. Our Quality Commitment is essential for achieving of our ambition goal; to be recognized as a trusted professional life science consultant. We believe that our services enhance the quality of life of patients and contribute to a healthier future of the pharmaceutical and healthcare industry. We at GRALC will never compromise of the quality of our services. This requires everybody in our organization to be engaged, to understand their responsibility and to be empowered to act to protect the quality of our services and our customers.

Essential elements of our Quality Policy:

Fostering a quality mind-set with the objective of developing and providing products and services with minimum defects
Complying with relevant laws and regulations and with our internal standards
Continuously improve our quality management system
Encourage participation and promotion of responsibilities amongst our employees, management and third parties through education, training and coaching, supervision, and effective communication
GRALC LLC has established Quality Objectives and a Quality Manual to establish our consistent Quality Management System (QMS) in line with the requirements of the ISO 9001:2015 Standard

Our Approach to Quality

At GRALC the quality of services can be defined as the embedded characteristics of our system.

The Quality Objectives are the characteristics of our system and ensure the high-quality desired outcome.

The Quality Objectives cover all elements of our operations:

Organizational structure,
Individual responsibilities,
Processes, procedures, and record management
Resource management,
Quality System, compliance, and deviation management,
Etc.

Our Quality System is based on all the following activities:

Quality planning: establishing structures and planning integrated and consistent processes.
Quality adherence: carrying out tasks and responsibilities in accordance with quality requirements
Quality control and assurance: monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out
Quality improvements: correcting and improving the structures and processes where necessary

This Quality Commitment applies to all our officers, directors, employees, and contractors. This “Quality Commitment” was approved by GRALC LLC management on May 25, 2016. Global Regulatory, Labeling & Compliance Services LLC (GRALC LLC)