Your Gateway to
Regulatory Success
At Pharmexon, we specialize in navigating the complex regulatory landscape to help our clients efficiently bring their products to market. We offer a comprehensive suite of regulatory affairs services, from submission management to sunset clause exemptions. Below are the subservices we provide, with detailed descriptions for each. Click on each subservice to expand and learn more.
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Submission Management Services
Pharmexon ensures meticulous planning and execution of regulatory submissions across multiple regions, including national and EU-wide submissions. Our experienced project managers oversee the process, ensuring all documentation is accurate, complete, and timely.
Marketing Authorisation Applications (MAAs)
Marketing Authorisation Holding
Marketing Authorisation Transfer
Pharmexon provides support for transferring marketing authorisations, handling the process from notification to approval. We ensure smooth transfers and manage the regulatory requirements across all EEA countries and beyond.
Article 61(3) Notification
Variation and Amendment Classification and Management
Renewals
Sunset Clause Exemption
Testimonials
References from our clients
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+420 602 378 935
Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia