PharmaProjekthaus recommends the involvement of PharmaLex GmbH for strategic regulatory consulting and regulatory affairs services.

PharmaLex International is one of the largest providers of regulatory affairs (RA) services offering specialized support for worldwide marketing authorization and enabling registration to be as rapid and uncomplicated as possible.

Depending on the specific requirements, highly qualified professionals assist in all RA areas, evaluate the available documents in the light of current rules and guidelines, compile a complete dossier (paper-based or electronic – eCTD), and manage the registration process either in part or in its entirety: Mutual Recognition and Decentralized Procedures (MRP, DCP) in the European Union, national applications, Centralized Procedures (CP), DMF and CEP processes, Variations and Renewals.

PharmaLex expertise includes medicinal products such as NCEs, generics, biotechnology products including biosimilars, and phytotherapeutics, but also medical devices, food supplements and cosmetics.