The document summarizes the results of a survey on medicine availability in Europe conducted with experts in May 2019. It finds that most European countries require companies to notify authorities and make public notifications when medicines are out of stock. Most countries allow for a temporary "soft launch" period when implementing serialization requirements to avoid penalties for technical issues. The top challenges with serialization implementation have been systems not being connected to databases and issues uploading data. Countries provide waivers to serialization rules in cases like packaging changes to avoid stock-outs.
The document summarizes the results of a survey on medicine availability in Europe conducted with experts in May 2019. It finds that most European countries require companies to notify authorities and make public notifications when medicines are out of stock. Most countries allow for a temporary "soft launch" period when implementing serialization requirements to avoid penalties for technical issues. The top challenges with serialization implementation have been systems not being connected to databases and issues uploading data. Countries provide waivers to serialization rules in cases like packaging changes to avoid stock-outs.
Process validation incorporates a lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.
Role and requirements of excipients in pharmaceuticals. Summary of new EU guideline published in March 2015 concerning risk assessment of excipients and excipient manufacturers.
Do you need consultation on the classification of biological active substances? Are you familiar with the documentation requirements? Do you need help in writing the documentation?
The document summarizes drug regulatory news from March 2014. It discusses new EMA fees for pharmacovigilance activities that will significantly impact pharmaceutical companies. It also outlines several ongoing safety reviews by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of various drugs like codeine-containing medicines, testosterone medicines, and medicines acting on the renin-angiotensin system. National regulatory authorities like Fimea are updating terms for modified-release pharmaceutical forms.
DRA Consulting’s medical translators combine their pharmacological expertise and knowledge of the
regulations and templates with fluent language skills.
Our specialists provide expertise in regulatory intelligence and strategic eRegulatory planning to help clients successfully manage their product lifecycles. We assist clients from the early preparation phase in publishing applications in eCTD/NeeS format and planning long-term eRegulatory strategies. In addition, we help with submissions to databases like EudraVigilance and can advise on registration and submission processes.
DRA Consulting provides marketing authorization and market access services for medicinal products throughout their lifecycle from documentation preparation to product launch and maintenance. They offer to act as a company's Nordic regulatory department through outsourced services providing additional expertise, capacity, and flexibility so clients can focus on their core business. DRA Consulting has special expertise covering regulatory affairs for pharmaceutical and biotechnology companies.
