Growth and sustainability are integral parts of our strategy, guided by our core values. By embedding sustainability in everything we do – from the lab to the patient – we are helping to strengthen good health and well-being. As the result of our in-depth market evaluation the most suitable medicines are outlined for our product portfolio. The safety and efficacy of our products is the top priority.
Manufacturing of pharmaceutical products is subject to very strict quality requirements – GMP (Good Manufacturing Practices), ISO certifications and the guidelines of the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). From complex requirements to tight production schedules, we along with our contract manufacturing organizations face stubborn obstacles in ensuring the wellbeing and health of humans while not harming the planet.
Protection against Product Counterfeiting
Product counterfeiting is an enormous problem worldwide. The Falsified Medicines Directive of the European Union specifies requirements and measures for the verification of the medicines. This includes mandatory security features on external packaging, which Kalceks has used for its prescription products since 2019. These data matrix codes are stored in country-specific databases across the EU. Wholesalers and pharmacies can verify the products authenticity by simply scanning the code.
Product safety monitoring
Our medicines need to be effective in treating the respective disease, while posing as little risk as possible to patients. Therefore, we consistently monitor risks and adverse effects that may arise and take the necessary actions to minimize them. Based on the conditions of regulatory approval, we develop and update educational materials for patients and healthcare providers to communicate any known and potential risks and ways to minimize them for newly approved products.
Ethics
Our core values – purposefulness, reliability, flexibility and responsive communication – guide us in our daily work defining how we interact with our customers and business partners. We do our business activities to adhere to relevant regulations and ethical standards around the world. We are aware that our company operates in a complex legal environment and incurs various tax obligations with its domestic and foreign business activities. It is our responsibility to ensure compliance with tax legislation in all countries in which we operate and to be transparent.
Code of Ethics
Environment
AS Kalceks as pharmaceutical company without own manufacturing sites, incorporates the green values for everyday office life, as example, waste recycling. Our logistics team also accurately plans product deliveries in order not to organize useless transportation activities. We also ensure that disposal of unused medicines strictly complies to legislation.
We aim to deliver our products in packaging that is safe and easy for customers to handled. We are working on for employing more eco-friendly materials for secondary packing. Our contract manufacturing organizations are covered by ISO 14001 certificate to comply with environment standards and to establish processes on improving efficiency in manufacturing of products to protect our climate and environment.