In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.
This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge if you are not familiar with country specific requirements. Read more about Understanding and delivering your EU Orphan Drug Launch
With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.
Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?
A failed chamber mapping study can lead to unnecessary costs in valuable biopharmaceutical production time or regulatory and product quality issues.
Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”
There are several guidelines from a myriad of agencies around the world that are available that cover Environmental Monitoring and Mapping In life sciences?
The parameters you choose to map in drug development and processing will depend upon your particular situation. Typical parameters for mapping are temperature, humidity, pressure, light and vibration. You must first determine the environmental parameter(s) critical to your system, process, and product. Assuming you are operating in a regulated environment, the critical parameters are most likely already documented in your cGMP files.
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