PharmaLex International is one of the largest service providers in Regulatory Affairs, well-established as a trustful, reliable partner to its clients. PharmaLex offers specialized support for worldwide registrations, enabling marketing approval to be as rapid and uncomplicated as possible.
Depending upon the specific requirements, PharmaLex’ highly qualified registration experts assist in all regulatory areas.
For EU registrations the PharmaLex network of local offices and partners ensure a trouble-free registration.
PharmaLex’ expertise includes medicinal products for human and veterinary use (NCEs, generics, biotechnological products, biosimilars, advanced medicinal products (ATMPs), etc.) as well as medical devices.
During drug development PharmaLex prepares clinical trial documentation (investigational brochure (IB), investigational medicinal product dossier (IMPD), clinical study report, scientific publications, etc.).
PharmaLex has long-standing experience in developing and implementing custom-tailored Pharmacovigilance strategies for medicinal products from early clinical stages through pre-marketing up to the established Pharmacovigilance activities in the post-marketing phase (Safety Specification, Detailed Description of Pharmacovigilance System (DDPS) and EU Risk Management Plan (EU-RMP), Periodic Safety Update Reports (PSUR), Safety Statement, Case Narratives, etc.).
PharmaLex offers to perform the compilation and writing of pharmacoeconomic evaluation dossiers for reimbursement and pricing strategies (value dossiers, “Nutzendossier”) according to national requirements.
Thanks to our comprehensive know-how and experience, our broadly based human resources and our organisational skills, we are in a position to be our clients’ partner throughout the entire lifecycle of their pharmaceutical products and medical devices.
Supporting our clients’ projects is our priority.
© 2013 BioRN Cluster Management GmbH • All Rights Reserved • Contact & Legal Notice