Helping to bring medicines to the market
The path of medicines to consumers is long. We help to ensure the availability of medicines throughout their lifecycle.
Our expert services support pharmaceutical companies in bringing medicines to the market, starting with clinical research, regulatory and market access services.
Once a medicine has a marketing authorisation, there are many obligations and requirements related to regulatory life cycle management that we help pharmaceutical companies to meet. This means, for example, maintaining marketing authorisations for human and veterinary medicines, translating and updating product information, and taking care of pharmacovigilance obligations, such as adverse-event receipt and processing.
Additionally, our Real World Evidence (RWE) studies can support patients’ access to medicines. By combining data from national and local registries with patient reported outcomes on medication use, the goal of RWE is to generate comparative data on standard of care and to demonstrate how the new treatment being advanced is an improvement over what is currently on the market.
Special licensed medicine to secure treatment
Sometimes there is no suitable licensed pharmaceutical for a patient due for example to allergies, incompatible dosage forms, a lack of the necessary pharmaceutical agent or disruptions in the supply chain. In this case, a doctor may decide to apply for special licence for use of a medicine that has no licence in the country.
Oriola’s special licence service helps to import medicines for human and veterinary use. Suitable options for the patient’s needs are investigated with pharmaceutical companies and foreign authorities. In the best-case scenario, the patient receives the medicine the very next day.