Regulatory Requirements Commitment
Specific Pharma’s business is conducted in compliance with applicable quality regulations, codes, and standards. Documentation and data are managed in accordance with applicable regulations. Quality is built-in in every step of operations, and through a robust Quality Management System (QMS) in place, we manage the required quality compliance at any stage of our business.
Continual Improvement
Specific Pharma continuously reviews all steps of operations to make them more agile, efficient, and up to date with the fast changes in national as well as international business scenarios. Our QMS is reviewed and improved alongside with these changes.
Ethics
Specific Pharma has a high standard of ethics. We are constantly aware that the services we provide affects people’s lives. Therefore, it is important to us to conduct our business in an ethical manner towards the patients, the authorities, and our partners.
Code of Conduct
The rules of conduct are contained in Phoenix Group’s Code of Conducts and apply to Specific Pharma. In this way, a total body of regulations have been established with the purpose of disseminating the culture of ethics and transparency within the company by offering the employees a guideline for their everyday behavior. At the same time, the organisation and management are implemented in accordance with Danish legislation.
Authorisations and Certificates
Specific Pharma’s authorisations are issued by the Danish Health and Medicines Authority based on the Danish Act.
We have a Wholesale Distribution Authorisation (WDA), which allow us to source and sell prescription drugs globally. We have an Authorisation of activities with euphoriant substances, which allows us to source and distribute controlled substances, globally.
Additionally, we have a Manufacturing and Importation Authorisation (MIA), which allows manufacturing activities and import of medicinal products form countries outside the EEA.
In the link below you can also find Specific Pharma's GMP- and GDP-certificates.
Download Specific Pharma's Authorisations and Certificates here.
Quality and Authorisations
CTSM combine profound quality insight with highly experienced staff in clinical trials in order to provide the best solutions for our clients throughout the supply chain for the clinical trials. CTSM is audited 10-12 imes per year by existing and new clients and with the solid and standardised processes, we are at all times audit ready.
CTSM is fully authorized by Danish Medicines Agency to import, manufacture amd distribute pharmaceuticals, controled drugs and clinical trial products. Furthermore, we ofer high quality standard ensuring study conduct compliant to GDP, GMP and GCP regulations.