Our Quality Approach

Quality is our fundamental value, bringing together trust in every product delivered to patients, scientific expertise, and our responsibility toward human health.

We manage the services provided by our headquarters—as a marketing authorization holder, importer, and contract manufacturing client—and the CMO/CDMO (Contract Manufacturing Organization/Contract Development and Manufacturing Organization) services offered at our manufacturing facility through an integrated, risk-based quality approach founded on the product lifecycle. In line with our roles and responsibilities, we safeguard patient safety and product quality throughout all processes, from regulatory approval, manufacturing, and analysis to supply, distribution, export, and post-market surveillance.

Our headquarters, manufacturing facility, and all business functions share responsibility for quality. We regard the contributions and cooperation of our employees, customers, suppliers, and other business partners as an essential part of the sustainability of our quality system. We make our decisions based on scientific data, objective assessments, and a risk-based approach.

We conduct our activities in accordance with applicable national and international legislation, European Union Good Manufacturing Practices (EU GMP), current Good Practice (cGxP) principles, and our Integrated Management System, which encompasses the ISO 9001 Quality, ISO 14001 Environmental, and ISO 45001 Occupational Health and Safety standards.

Yeliz DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Chair of the Board

Aydın Demir

Dem İlaç San. Ve Tic. A.Ş.

Vice Chair of the Board

Deniz Martin DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Member of the Board

OUR QUALITY POLICY

To ensure and continuously improve product quality in line with patient safety, customer needs, and future expectations.
To comply with the requirements of the TS EN ISO 9001 Quality Management System, European Union Good Manufacturing Practices (EU GMP), current Good Practice (cGxP) principles, applicable legislation, and relevant quality standards, and to continuously improve our system.
To preserve the quality, safety, and efficacy of our products throughout their lifecycle and monitor them using our performance indicators.
To conduct our manufacturing and CMO/CDMO activities in accordance with customer requirements, quality agreements, technical agreements, and applicable regulatory requirements.
To manage our processes in accordance with scientific data, data integrity, traceability, and a risk-based approach.
To systematically assess quality risks and opportunities arising from processes, changes, and external conditions.
To maintain strong supply relationships and evaluate our suppliers and business partners with a quality-focused approach.
To ensure that products are stored and shipped in accordance with the specified quality, storage, and transportation conditions.
To encourage our employees’ active participation in the quality culture, support the development of competencies appropriate to their roles, and ensure awareness of their quality-related responsibilities.
To improve process efficiency by utilizing technology and digitalization and to operate through proactive, planned, sustainable approaches that adapt to changing conditions.
To reliably bring products that meet our quality standards to market through strong sales strategies and support sustainable growth based on customer satisfaction.
- To strengthen our success within the industry and remain a preferred organization that sustainably enhances its market position.

Yeliz DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Chair of the Board

Aydın Demir

Dem İlaç San. Ve Tic. A.Ş.

Vice Chair of the Board

Deniz Martin DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Member of the Board

OUR OCCUPATIONAL HEALTH AND SAFETY POLICY

To follow emerging technologies and methods relating to occupational health and safety in comparable industries and worldwide and to implement applicable solutions within our organization.
To fully comply with the requirements of the TS EN ISO 45001 Occupational Health and Safety Management System and applicable legislation and to continuously improve our system.
To maintain occupational health and safety at the highest level and prevent occupational accidents, occupational diseases, and work-related ill health.
To conduct our manufacturing and CMO/CDMO activities in accordance with customer requirements, quality agreements, technical agreements, and applicable regulatory requirements.
To systematically assess occupational health and safety hazards and risks, including those arising from changes, new technologies, new working methods, and other variables.
To eliminate hazards at their source and, where this is not possible, assess and reduce risks through appropriate control measures.
To protect the health and safety of our employees, subcontractor personnel, visitors, and other individuals who may be affected by our activities.
To control at an early stage hazards that could lead to accidents, occupational diseases, damage, or emergencies; take the necessary precautions; and maintain emergency preparedness.
To ensure that our employees and subcontractor personnel receive all required training fully and on time and to encourage their active participation in occupational health and safety processes.
To measure, monitor, and evaluate our occupational health and safety performance and implement the necessary improvements based on the results.
- To continuously strengthen occupational health and safety awareness among our employees and make a safe working culture an integral part of our corporate culture.

Yeliz DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Chair of the Board

Aydın Demir

Dem İlaç San. Ve Tic. A.Ş.

Vice Chair of the Board

Deniz Martin DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Member of the Board

OUR ENVIRONMENTAL POLICY

To prioritize environmental protection and environmental safety across all our activities.
To identify the environmental impacts of our activities using a lifecycle approach and prevent or minimize pollution at its source by systematically managing environmental risks.
To comply with the requirements of the TS EN ISO 14001 Environmental Management System, applicable environmental legislation, and related obligations and to continuously improve our system.
To allocate the necessary resources for protecting and improving the environment and utilize scientific and technological developments by considering environmental risks and opportunities in our investments, technologies, and processes.
To use natural resources, water, and energy efficiently; support the use of clean energy through our renewable energy investments; and contribute to reducing our carbon footprint and greenhouse gas emissions.
To reduce waste generation and ensure that waste is separated at its source, recovered, and managed safely through the practices implemented under our Zero Waste Certificate.
To enhance our environmental sustainability and corporate resilience by assessing the effects of climate change on our activities.
To evaluate our suppliers and business partners according to their environmental approaches and develop transparent and sustainable cooperation aimed at protecting the environment.
To evaluate the use of renewable energy and more environmentally efficient technologies in areas where they are technically and economically feasible.
To continuously strengthen our employees’ environmental awareness through training, communication, and participation and to monitor our environmental objectives, targets, and performance.

Yeliz DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Chair of the Board

Aydın Demir

Dem İlaç San. Ve Tic. A.Ş.

Vice Chair of the Board

Deniz Martin DEMİR

Dem İlaç San. Ve Tic. A.Ş.

Member of the Board

Acting Responsibly, Moving Forward with Our Values

Our Quality Approach

OUR QUALITY POLICY

OUR OCCUPATIONAL HEALTH AND SAFETY POLICY

OUR ENVIRONMENTAL POLICY

Our Certificates