Ask DRA to take care of all the processes you need for successful wholesale functions. We offer a comprehensive service that handles applications for and maintenance of GDP licenses, as well as management of your quality systems and product complaints in all Nordic countries.
Our pharmaceutical wholesale services include:
- License applications
- Responsible pharmacist services
- Establishing and managing QMS
- Preparation and updating of standard operating procedures (SOPs)
- Audits and inspection preparations
- Supply chain and distribution
- Product quality complaints procedure
- Narcotic issues and mandatory reserve supplies
Get DRA to handle your wholesale processes to ensure the availability of your pharmaceutical products. Our services include preparing applications for wholesale licenses, establishing quality management systems (QMS), as well as responsible pharmacist services. Our team can help you from the very start of the planning phase onwards, and they have extensive knowledge of Good Distribution Practices (GDP), as well as national requirements and procedures.
Marketing authorisation holders must have a system in place for dealing with product quality complaints (PQCs), however the process can be very time consuming for companies. At DRA, we offer a complete service to lighten the load on your team. We will take care of every aspect, from receiving complaints and recording them in the appropriate systems, to pursuing follow-up questions from customers, all the way through to providing the final response and reports to the customer. Our large and experienced team are very familiar with the process and they have the capability to handle high volumes of product complaints while meeting strict timelines according to your standard operating procedures. Naturally, they can also handle all complaints in the local Finnish language.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.
EU Council to postpone the MDR deadlines
The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients.