As one of most leading pharmaceutical companies of Iran, tekaje considers the quality policy as an important and substantial part of our strategy. It places emphasis on the continuous improvement of its services and products. This is achieved through successful periodical implementation, maintenance and updates of the quality management of tekaje, enhancing satisfaction of customers and other beneficiaries and also guaranteeing long-term profitability. Ensuring that the above procedure is carried out is essential to fulfilling the company’s mission statement and to the overall persistence of the company. It is quite evident that the efficiency, quality and trustworthiness of the imported and manufactured products of the company have a substantial role in the long term success of this economic enterprise.
The basic principle in the quality policy of tekaje is the notion that research and development, production, marketing and sales processes should be based upon internal and international quality standards GMP, GDP, GSP in order to meet customer requirements. To realize this important objective, the company seeks to establish a safe quality management system that is reflected in all aspects of management, research and development, import, production, marketing and sales.
Taking into account the strategy of tekaje - to focus on research and development to enrich its product portfolio through innovation and the use of new technology, thereby satisfying the needs of customers and ensuring the profitability of shareholders - every senior manager and employee is closely committed to executing the quality management system within the company. This unanimous attitude towards quality management necessitates the existence of a system but every single employee should also promote their personal quality through self-criticism regarding the duty entrusted to them and everyone should be accountable for the qualitative results of their own performance.

Objectives:

• Optimization of economic activity of the company based on optimization of the quality of products, innovation and creative services.
• Obtaining satisfaction of all beneficiaries.
• Continuous detection, evaluation, omission, and/or controlling of all environmental, safety and hygienic risks related to all activities in normal, change and crisis periods, with emphasis on companies activities.
• Continuous improvement of all working fields and aspects of the organization.
• Continuous promotion of personnel skills, knowledge, and motivation, team work through sustained, dynamic and efficient training.
• Creating a “quality culture” in all employees in order to move towards organizational excellence.
• Implementation and maintenance of GMP requirements and Integrated Management System (IMS) together with productivity and continues improvement orientation, and obtaining the related accredited local and international certificates.
• Creation and development of integrated information systems.
• Optimized management of resources, energy and waste, and conducting environmental and safety hedging actions.
• Research and innovation in the field of service rendering and production of novel medicinal products.

Our production plant is providing leadership with new high-tech facilities in Eschtehard which is a pharmaceutical industrial zone of the Alborz province in Iran.
The facility was designed by a European pharmaceutical consultancy company according to high standards of cGMP. It has earned us a GMP certificate by the Iranian authority, ISO 9001 and ISO 14001 certifications.
All production equipment used at the plant is state of the art and meets all GMP and GLP requirements.
A $10 million-dollar investment was made in the facilities, which were built using the modern environmentally friendly technology in an area of 5000 m2, and operating on two shifts with an annual capacity of 350 million units.
Operations are continually being developed through technological investments and automation and are carried out employing production management system applications within closed systems, which increase traceability and efficiency.

The following items are made and packaged with the Solid Manufacturing and Packaging division:

• Tablets
• Film Tablets/ pills
• Capsules
• Pellets
• Sachets

The research and development department of tekaje is in operation since 2007. The tekaje pipeline includes more than 40 molecules. In view of recent rapid developments. tekaje is also specializing in various therapeutic areas.
Tekaje has recently been investing heavily in the infrastructure and facilities for its R&D laboratories to make them state of the art and efficient. This has enabled scientists and experts at the R&D department to troubleshoot major bugs in the formulation of the most chemically complex medicines and to come up with high quality products.
Tekaje R&D department is composed of three units; formulation, analysis, and documentation.

Different pharmaceutical dosage forms such as sachet, tablets, F.C tablets, sustained release tablets, and oral dispersible tablets, and etc. are formulated in this unit.
Before any development is initiated in pre-formulation studies, the drug molecule is characterized for certain fundamental physical, chemical, and physico-technical properties. The corresponding properties are then taken for reference to the brand originator. To reach the final trial, all formulas comparable with those of the brand drug must be re-analyzed with strict criteria at the analysis unit. Stability of structures is assessed after packaging samples and putting them in an accelerated stability chamber.
Instruments, which are used in this unit, include rotary presses, tablet coating system, mixer, oven, accelerated stability chamber, automatic LOD tester, hardness tester, PH meters, disintegration time tester, and friability tester.

In this unit, prototype products include solids, syrups, and sachets. Analysis of different dosage forms of the final trial formulae are carried out according to the pharmacopeia monographs or in-house methods of analysis. If necessary, the method of analysis may be developed for new dosage form or a new drug.
Endurance tests are done according to ICH standards to determine the stability of experimental batches of new products and various packaging containers. The stability of the trial batch of each product is also tested in this unit and the results of the assessment are sent over to the documentation unit in order to complete the CTD document and send it to the bureau of Food and Drug Administration.
This unit is equipped with facilities such as Dissolution apparatus, HPLC, UV spectrophotometer, etc.
Analysis results of in-vitro studies in this unit are very important for the optimization of the formulation and completion of the CTD document.

CTD documents, which are required for final approval and licensing by the FDA bureau, are prepared and developed in the course of production process in this unit. These documents include drug manufacturing methods and formulations, analysis documents of ingredients, excipients and product, packaging items documents, and sustainability reporting.
Developed methods, SOPs of instruments, and MSDS of materials are also carefully prepared and reported in this unit.

While scaling up production, the formulation and analysis unit supervises and solves any probable issues.
Thus, new product manufacturing and analysis methods continue to ensure the quality control of the operation and the delivery in the course of manufacturing of semi-industrial and three industrial batches production.

In Regulatory Affairs we obtain the licenses needed to bring high quality therapies to patients and caregivers in Iran where tekaje operates.
The role of Regulatory Affairs continues throughout the lifetime of a medicine and consumer healthcare product, with involvement in advertising, labelling and the monitoring of safety.
In tekaje’s regulatory affairs we engage in close dialogue with our Health Authority which is Iran Food & Drug Administration (IFDA) to secure favorable, sound and informed decision-making in all phases of registration process - for the benefits of the patients.
We strive to be responsive to business needs of ourselves and our partner’s corporate, and to minimize time to marketing authorization while ensuring compliance in a changing regulatory environment. This is accomplished via forming specialized teams for imported, in-licensed and locally manufactured medicine and dietary supplements, supervised by their own team leader and qualified pharmacist.
Regulatory Affairs had several milestones by solving bottleneck issues with the IFDA including fast track registration of certain products, introducing new molecular entities to Iran pharmacopeia, brand product registration, skipping many site audits and managing document discrepancies and deficiencies.

Availability, consistency and delivery:
Tekaje is distributing pharmaceutical products to approximately all 10,000 pharmacies in the Iran.
Our infrastructure is large and well-supported by dozens of warehouses, delivery trucks and supplier relationships in every corner of Iran.
Both the infrastructure and underlying system is validated & certified by multinational pharmaceutical companies and competent regulatory bodies for their distribution practices, which is in line with highest standards of the Industry as described by the GDP.
Our customers attribute their high satisfaction to our ‘speed of delivery’, ‘people who are well trained to offer high quality services for benefits of customers’, ‘personal attention and responsive service’ and ‘efficient use of information technology’.

Tekaje sales & marketing serves 4 groups of stakeholders.
In developing a strategy to maximize opportunities, we leverage a thorough analysis of the healthcare environment, in order to analyze core issues and create strategic and tactical recommendations.
Our marketing begins with identifying our market stakeholders, classifying them based on their decision criteria and engaging their heart and mind with our brands.
In Iran we have 110,000 healthcare practitioners (HCPs) carrying main responsibilities for the wellness of more than 75,000,000 people.
HCPs that are specialized in a certain therapeutic field become members of their relevant medical associations. These associations are the most regarded in terms of scientific issues, setting treatment guidelines, conducting clinical trials, encouraging new molecules acceptance by IFDA and encouraging insurance coverage of medicines. Their role is very significant, and along with the KOLs who are nominated as their board, they form a distinct group of stakeholders.
90% of Iranian are under insurance coverage. The insurance companies (payers) are now adopting treatment protocols to avoid selective individual prescriptions. They also require a justification for the value against price to include/keep medicines on their lists.
Finally in the value chain we also interact with wholesalers who logistically distribute our medicines to 10,000 pharmacies and 11,000 hospitals to be consumed by patients.

Our marketing principle is to create and communicate shared value with our stakeholders within the framework of our due diligence guideline. The value which is relevant to their expectations and needs.
The nature of our interaction with KOLs and medical associations is mostly to facilitate resources for their research. Specifically tekaje line/product supervisors and senior medical advisors are responsible to manage these key accounts.
For HCPs, our team of medical representatives pre-arrange meetings and give information about our products, collect their feedback and report to their supervisors for data analysis. For best results, our medical representatives spend several hours a month in training.
HCPs can choose their preferred model of communication with our company, so we can manage our future detailing.
The payers are given pharmaeconomic studies proving how medicines are more effective and economical compared to other forms of interventions. The reports are prepared by our market access manager.
Pharmacies, hospitals and wholesaler are commercially dealt with in terms of payment and price facilitation against unit sales. Our sales manager and his team are responsible for maintaining and enhancing this communication.
Finally, patients are given free medical consultations via phone and email 24/7, and are advised by our medical manager in case of any emergencies.
Patients can also reach the relevant content about their health issue via the upcoming tekaje Life website.