When it comes to regulatory affairs services, Pharmexon’s expertise lies in navigating the complex regulatory landscape, ensuring that the clients meet all the necessary requirements to bring their products to market efficiently and effectively. Pharmexon offers a comprehensive suite of services that cover every aspect of the regulatory process, from submission management to sunset clause exemption.
At Pharmexon Consulting, the understanding that successful regulatory submissions require meticulous planning and execution is evident. Using extensive experience in managing submissions across multiple regions, including national applications and EU-wide submissions, Teams of skilled project managers oversee the entire submission process, ensuring that all documentation is accurate, complete, and timely.
Offering full support for Marketing Authorisation Applications (MAAs), Pharmexon Consulting guides clients through the complexities of national, Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and Centralised Procedure (CP) applications and other worldwide submissions such as NDAs, 505b2 (USA) ], IRP to MHRA and to other stringent authorities. Pharmexon’s team have in-depth knowledge of the requirements for each type of application, allowing the provision of tailored advice and support, from initial submission strategy to a successful grant of the marketing authorisation.
Pharmexon Consulting can act as the Marketing Authorisation Holder (MAH) for clients who require this service. As an MAH, Pharmexon takes on the responsibility of maintaining compliance with all regulatory obligations, including pharmacovigilance, quality assurance, and product recalls, allowing clients to focus on their core business while the regulatory aspects are handled.
When a marketing authorisation needs to be transferred from one entity to another, Pharmexon Consulting provides comprehensive support. The entire process is handled from initial notification to final approval, ensuring a smooth transfer. Using a group of experienced individuals, Pharmexon is experienced in dealing with the regulatory authorities and understands the specific requirements for MA transfers throughout all EEA countries and beyond.
Pharmexon Consulting offers guidance and support for Article 61(3) notifications covering changes to a product’s labelling or patient leaflet. By assisting clients in preparing and submitting the necessary documentation, Pharmexon ensures compliance with regulatory requirements while constantly staying updated on the latest changes in regulation, allowing accurate Article 61(3) advice to be made.
Managing variations to marketing authorisations can be complex. Pharmexon Consulting helps clients classify and manage all kinds of variations, ensuring they are properly documented and submitted to the regulatory authorities. Clients are guided through the submission process, working with Pharmexon to determine the correct classification for each variation.
Marketing authorisations must be renewed periodically to remain valid. Pharmexon Consulting supports clients in preparing and submitting renewal applications, ensuring that all requirements are met. The entire process is managed, from gathering necessary data to liaising with regulatory authorities, helping clients maintain their marketing authorisations without interruption.
The sunset clause requires that a product be put on the market within three years of the marketing authorisation being granted, or it may be revoked. Pharmexon Consulting assists clients in obtaining exemptions from the sunset clause when needed, helping clients to prepare the required documentation and advocate on their behalf to regulatory authorities, ensuring that their marketing authorisations remain valid.
With Pharmexon Consulting, clients can be confident that expert guidance and support throughout the entire regulatory process is received. Using Pharmexon’s wide list of comprehensive services, clients are ensured that regulatory compliance is achieved efficiently and effectively, allowing them to focus on their business goals.
+420 602 378 935
Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia
