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.

At Pharmexon, we don’t just navigate the regulatory complexity —we redefine the path to success.
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.

We guide clients through the complexities of various application procedures, including Decentralised, Mutual Recognition, and Centralised Procedures, as well as global submissions. Pharmexon’s team offers tailored advice from strategy to successful grant of marketing authorisation.
Pharmexon can act as the Marketing Authorisation Holder (MAH), taking on the responsibility for compliance with all regulatory obligations such as pharmacovigilance, quality assurance, and product recalls, allowing clients to focus on their core business operations.

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.

We assist clients in preparing and submitting the necessary documentation for changes to product labeling or patient leaflets, ensuring compliance with Article 61(3) of the EU directive, while staying up-to-date on regulatory changes.
Pharmexon helps clients manage variations to marketing authorisations by properly classifying and submitting variations to regulatory authorities. We guide clients through the submission process, ensuring all variations are properly documented and compliant.
We manage the entire renewal process for marketing authorisations, ensuring that all requirements are met and submissions are prepared and submitted on time, maintaining validity without interruption.
Pharmexon assists clients in obtaining exemptions from the sunset clause, which could otherwise revoke a marketing authorisation if a product is not put on the market within three years. We ensure that necessary documentation is prepared and advocate on behalf of our clients to maintain their authorisations.

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+420 602 378 935

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Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia