Akman Pharma’s portfolio includes novel branded pharmaceutical products of high therapeutic value. Most of these pharmaceutical products are intended exclusively for hospital use, and are designed to meet therapeutic needs of patients.

Ensuring high quality of our medicines and patient safety are top priorities for us.

To assure quality of our products and services:
We have set up appropriate standards that meet international quality standards for the proper transport and storage of our pharmaceutical products The logistics fully comply with a documented Quality Management System All actions that can potentially affect quality, are planned and implemented according to established procedures, which have been developed based on the “in process” approach of the Quality Management System MS) All control data are analyzed and used to ensure that the distribution of our products abides by the EU and international legislation, that proper storage conditions are constantly met and that continuous improvement of the Quality Management System is achieved We apply a comprehensive pharmacovigilance system for reporting and managing any adverse effects associated with any of our products We have developed an efficient Risk & Crisis Management System to address any emergency situation and ensure smooth delivery of our services to our customers.

Our company has appointed a Quality Manager with the authority and organizational independence to ensure that the Quality System is operated and observed according to the ISO 9001 standard, as well as the statutory guidelines and legislation.

The Quality Manager is also responsible for the management of Product Technical Complaints.

A Product Technical Complaint is defined as any report implying product failure in regards to labeling, identity, strength, purity, quality, or stability or possible product incompatibility with its specifications.

If you wish to report a Product Technical Complaint please contact: info@akmanpharma.de

At Akman Pharma we follow high quality standards and fully comply with legislative requirements as well as GDP and cGMP guidelines so as to ensure quality of our medicines, quality of the services we provide and customer satisfaction.

Since its inception , our company has been applying a certified Quality Management System for the activities of “Import, Storage, Distribution and Sales of Pharmaceutical Products” according to the international ISO 9001 standard.

Within the scope of our Quality Policy, the Management has set specific key quality objectives, which are reviewed on a regular basis and which aim the following: ensure quality of pharmaceutical products supplied improve speed of customer service improve quality of services provided care to maintain high customer satisfaction and minimize complaints.

Is defined by the World Health Organization (WHO) as ’the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’.

All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored so to assure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. Furthermore, if a medicine is labelled with the black triangle, this means that it is being monitored even more intensively than other medicines.

Regardless of your position (health professional, patient, etc.) by reporting a suspected adverse drug reaction, you actively contribute to the ongoing monitoring of the safety and quality of our medicinal products. If you wish to report a suspected adverse reaction related to our drugs, please contact us at: info@akmanpharma.de

All information collected during the reporting of an adverse reaction is confidential and anonymised, regarding both the reporter and the patient.

The Regulatory Affairs department of Akman Pharma LTD. ensures the effective management of regulatory requirements for the entire product portfolio and at all stages of a product’s lifecycle, capitalizing on the broad scientific knowledge and experience of its specialized, highly trained professionals.

It safeguards the compliance of both products and company functions with all applicable laws, regulations, and directives of the pharmaceutical regulatory framework. It serves as the company’s liaison with local and international Regulatory Authorities for obtaining and maintaining the marketing authorizations of its products, cooperating with all global partners and the company's representative offices to this end.

The Regulatory Affairs department works closely with all business units aiming to help them fully comply with regulatory guidelines that affect their activities and transform regulatory requirements into applicable and operational plans. Its ultimate goal is to support the company's vision for patient access to innovative therapies with high standards of quality, safety and efficacy.

We ensure that quality of our products is observed at every stage by applying storage and distribution systems of advanced technology. Akman Pharma adheres and is fully compliant with strict GDP (Good Distribution Practice) standards of the European Medicines Agency (EMEA). Thereby ensuing ensuring proper storage, preservation, and distribution of pharmaceutical products, which are extremely sensitive to external conditions of temperature and humidity and for which storage and transport require very stringent specifications.

Strict Distribution Standards;
For us, the process of product distribution is highly significant and crucial. Thus, we have established several validation methods to ensure proper and timely delivery of products:

a) Contract only with certified transport and logistics partners for strict compliance of delivery of all orders.

b) Order Delivery Tracking. All deviations from the estimated time of delivery are recorded.

c) Letters to customers with handling instructions upon product delivery. The company wishes to be informed in case of any problems upon product delivery.

d) Random checks with on-site visits to customers by the Quality Manager in order to check delivery and storage status of the products.

e) Special handling instructions (e.g., storage conditions, fragile etc.) of pharmaceutical products are attached on the outer packaging of shipped products.

f) Checks with on site visits to Akman Pharma LTD. subdistributors and local offices by the Quality Manager in order to monitor the way of storing and distributing the company's products to all countries in which the system is run.