We have many years of experience from orphan and niche pharmaceuticals sales. On a global or European level, product strategy and tactics is managed through an integrated brand team structure led by dedicated brand directors. They work closely with the local teams with extensive networks among KOLs, physicians, patients and other healthcare providers.
We have an in-house digital marketing department and we are actively using digital channels in our marketing efforts. Read more about our digital marketing.
We are members of pharmaceutical industry trade associations in several countries, and naturally work with high ethical standards.
Sobi Partner Products always has patients’ health in mind. We go through great lengths to ensure patients can get access to potentially lifesaving medicines. One aspect of this is to support the correct use of our products before registration is obtained, so called Named Patient Use (NPU). In our portfolio we carry several products which are provided on a NPU base. Consequently, Sobi Partner Products has extensive experience of NPU sales. Especially in the field of Oncology and Haematology have we been able to support and make available innovative treatments to patients with serious conditions. Another area where NPU usage has been instrumental to provide access to life saving medicines is various poisoning conditions. Many lifesaving antidotes are not available as registered drugs, and hence the only way for patients to get access to these treatments would be via the NPU route.
The most important factor in correctly managing name patient usage is solid local medical expertise. This is critical in order to ensure that the requesting physicians have the right knowledge and correct scientific understanding of the medicine and usage thereof. Another important factor is to have a well-established local regulatory competence, in order to fully comply with local legal and regulatory settings. Last, especially in acute situations like in poisoning cases, it is imperative to have a developed logistic network across EU especially tailored to manage small quantity orders in a speedy way.
We are proud to say Sobi Partner Products over the years have gathered the experience and capabilities to fully meet the standards required to in a compliant and effective way manage Name Patient Use across Europe.
During the past years, we have been developing our central and local market access capability and knowledge to address and adapt to the ever changing needs of the health care sector both from a patient and clinical perspective as well as from a payer and affordability perspective. We continuously work to broaden and strengthen our expertise especially in the field of rare diseases and specialty products to make sure we have a thorough understanding of these highly complex and dynamic healthcare systems.
The Supply Chain department ensures supply to patients at all times. In close cooperation with the partner’s planning organization, we manage stock levels based on sales, forecasts, life-cycle phase, shelf-life and other parameters. We are also responsible for the order-to-cash process, local warehousing and transportation through our European distribution network, including cold chain management. We have internal order handling and customer service for complex orders with special requirements, and ensure customs and trade compliance.
The safety of the patient is a priority for Sobi. The Drug Safety Department is responsible for collecting and reporting safety data relating to the use of Sobi Partner products. We regularly train all our staff to identify and report any potential adverse drug reactions with our products. The information is shared with and evaluated by our business partners with the aim of identifying any new safety information relevant to patients, prescribers and health authorities.
Sobi Partner Products can provide regulatory assistance and advice in managing all kinds of regulatory submissions, such as Marketing Authorization Applications, variations, renewals and maintenance activities, both on an EU and national level in all European countries as well as other territories outside Europe.
We are also experienced in regulatory activities related to product development such as Clinical Trial Applications/INDs, Orphan Drug Designations, Scientific Advice/Protocol Assistance, and Pediatric Investigation Plans.
In order to handle pharmaceutical products one needs to take into account several laws and regulations. Compliance with the highest quality standards as per Good Distribution Practice (GDP) is our key priority in the procurement, storage and delivery of products.
Sobi Partner Products has a comprehensive quality assurance system to meet the strict quality requirements of the pharmaceutical industry and our customers, as well as to comply with the applicable regulations concerning pharmaceutical products as set forth by the relevant authorities. Our quality system comprises of several Standard Operating Procedures (SOPs), in which our employees are trained.
Sobi holds a licence concerning import from outside EU as well as a wholesaler dealer’s license. An appointed Qualified Person is stated on the licences as the person responsible towards the authorities. Sobi is regularly inspected by the authorities as well as customers using Sobi´s services.
When applicable, Sobi has the possibility to hold goods in quarantine before EU release or manage local release of products derived from blood or plasma, everything according to approved procedures.