supervisions of suppliers

Who We Are:

Since its establishment in 2007, Quality Academia has been providing services successfully to many national and international organizations n areas such as pharmaceuticals, biotechnology, medical devices and hospital & laboratory services. With its experienced team consisting of hundreds of engineers, architects, project supervisors, inspectors, consultants and trainers, in Europe, Middle - East and Africa, Quality Academia provides services in 5 main areas which are;

- Turnkey Facility Project Solutions

- GMP, GDP, 3rd Party Storage & Distribution Service Provider Audit Solutions

- Regulatory Solutions

 - Project Management & Business Development

- Seminars – Conferences - Workshops Solutions

It is one of the most important duties of Quality Academia’s expert team to provide their clients compliance with current guidelines and regulations and local laws continuously.

Quality Academia has specialized in turnkey facility solutions. It provides state of the art solutions to customers from different industries often exceeding their expectations starting from the idea stage of the project through the final step, at a satisfaction level appropriate for the directives and guidelines of most strict authorities.

From the growth and renovation of your present business to the establishment of a new site, as a single source Quality Academia takes great pride and joy in working with you for all your project requirements for a wide variety of services.

Following the first meeting and interview with our customers, we undertake an advisory role throughout the project life for concept design, basic design, detailed engineering, construction management, qualification, start-up, validation, and training and in many more stages.

The Commitment for Servicing from a Single Source; (A single Source Service Provider)

Apart from numerous advantages of being a company that can undertake all responsibilities of in the whole process from the initiation of a project to the final stage, we ensure that our customers save time, effort, and manpower.

We take pride in completing the projects often in a much shorter time when both design and construction is under our responsibility as a single company.

Total cost of the project is determined during the first meeting and clearly described in to the contract, and will only be amended for minor changes with clients prior approval. Working with less suppliers and contractors is the main and one of the most important factors that reduces the costs. The Quality Academia's expert team undertakes all responsibility as indicated in the contract at project initiation with this sense of responsibility and ensures that customers use their time, efforts, and manpower more effectively. It is a fact that starting your project with our experienced and expert consultants will prevent unexpected future surprises to minimize all unexpected costs.

Audits - is another area of services specialization for which we at Quality Academia, are very proud of.

Quality Academia provides "Assessment for Audit Preparations" service to the customers before they are audited by the authorities. It determines areas to prioritize in terms of GMP & GDP Compliance with a risk-oriented approach as per requirements of T.R. Ministry of Health Turkish Drug and Medical Device Institute, Ministry of Food, Agriculture and Livestock, FDA, EMA, PIC/S, MHRA, TGA, WHO etc.

We will highlight very clearly which areas, equipment, systems, processes, procedures the authority auditors will focus on. This evaluation is generally performed with a detailed study that lasts 1-2 workdays. The primary goal of our consultants and auditors is reviewing the functions of your GMP-Compliant Quality Management Systems. A detailed report, with recommendations clearly described, is presented at the end of our evaluations. All of the determined non-conformities, observations and suggestions are included in the report which will provide the opportunity of addressing the deficiencies before the audits.

GMP Audits/Audits:

  • API (Active Pharmaceutical Ingredient) Supplier & Manufacturer Audits
  • Excipient (inactive ingredient) Supplier & Manufacturer
  • Packaging Material Supplier & Manufacturer (Primary /Secondary)
  • Contract Manufacturing Site
  • Laboratory – Production - Warehouse
  • GMP Compliance
  • FDA, EMA, MHRA, TGA, PIC/ S, WHO, etc.

Regulatory Activities:

We provide consulting services in the following areas:

Pharmaceuticals, Biotechnology, Biosimilars, Generics, Medical Devices, OTC Products, Herbal Medicinal Products, Cosmetics, Food Supplements, Functional Foods, Veterinary Medicinal Products and Radiopharmaceuticals.

Seminars-Conference-Workshops:

We provide solutions to our customers in more than 100 areas such as GMP, Quality Management, Qualification, Validation, Quality Control, Stability, Supply Chain, Audits etc.

We organize 2-3 days conferences at popular and attractive areas in Turkey which provides opportunities to meet specialists and your peers at the orientation meeting during short breaks and dinner meetings. We will assist you in choosing the most suitable hotel for you from the hotels we have agreements with, to make the stay of the participants successful and comfortable.

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