PharmaLex International supports drug applications, enabling rapid registration in Europe, the US, Japan and other regions worldwide.
PharmaLex’s regulatory affairs experts are pharmacists, medical scientists, chemists and biologists who make sure that you have optimal support for all aspects of your drug registration.
PharmaLex knows how to manage the interdisciplinary tasks so that the different departments of your company can work efficiently together. To cover the whole process PharmaLex relies on a network of experts in pharmaceutical, pharmacological, toxicological and clinical (CRO) areas, as well as production and sales.
Expertise in mutual recognition procedures (DCP, MRP), centralised procedures, DMF and CEP processes, and CTAs
Based on more than 20 years of regulatory affairs experience, PharmaLex elaborates the most promising strategies when launching your product on the market.
PharmaLex’s highly qualified registration experts assist in all fields of regulatory affairs; for example, evaluation of documents in view of current rules and guidelines, compilation of the complete dossier (paper-based or electronically – eCTD) and the management of either parts of or the entire registration process. Mutual recognition procedures in the EU (MRP and DCP), national applications, centralised procedures (CP), DMF and CEP processes, CTAs, variations and renewals are all covered by PharmaLex’s expertise. For EU registrations PharmaLex’s network of local offices and partners ensure a trouble-free registration.
Areas of expertise include medicinal products for human and veterinarian use, such as NCEs, Generics, ATMPs, biotechnological products, biosimilars and phytotherapeutics, as well as medical devices, food supplements and cosmetics.
Pharmacovigilance strategies for drug registration
PharmaLex’s experts develop and implement custom-tailored Pharmacovigilance strategies for your medicinal product as well as for your medical device, from early clinical stages through pre-marketing, up to the established Pharmacovigilance activities in post-marketing stages. In addition, during the approval process we provide the safety specification, detailed description of Pharmacovigilance system (DDPS) and EU risk management plan (EU-RMP) to be submitted at the time of licence application of your drug.
PharmaLex assists you in all issues concerning paediatric investigations. Experts sort your current documentation and investigate the existing studies for your intended paediatric indication. PharmaLex evaluates the results of the studies and writes expert reports, supports your strategic planning and evaluates the potential for deferral or waiver, and compiles your PIPs or PUMAs.
Custom-tailored drug registration services
PharmaLex manages either parts of or the whole of your registration process – it’s your choice. Besides competent consultancy, the strategy-related tasks include:
Application for clinical trials (CTA, IMPD and IND)
Evaluation of documentation on the basis of existing rules and regulations (quality, efficacy and safety) and the supervision of related tasks
Writing of individual documents of the CTD-modules 2-5 (chemical-pharmaceutical, pharmacological / toxicological and clinical)
Writing of quality overall summaries (QOS), nonclinical overviews, summaries and clinical overviews
Writing of Active Substance Master File / European Drug Master File (ASMF/EDMF) and US-DMF
Preparation of SmPC, patient information and labelling, PIL ‘User Test’
Preparation of briefing packages for meetings with authorities
Scientific advice procedures (national authorities, EMEA and FDA)
Compilation of the complete CTD, eCTD dossier Module 1-5
Company individual hosting of electronic dossiers (eCTD)
Training courses in all regulatory domains
During the registration process PharmaLex deals with the preparation and submission of the dossier, the supervision of the official registration process, communication with the authorities and translation of product texts into local languages. PharmaLex also responds to deficiency letters and meets mandatory and company-defined timelines.
Life-cycle management, regulatory compliance, renewals and line extension
After drug registration, PharmaLex provides guidance and expertise regarding:
Life-cycle management, paper-based or eCTD-LCM
Adherence of regulatory compliance / maintenance
Reformatting (CTD to eCTD)
Pharmacovigilance, PSURs and AE reporting
PharmaLex was founded in 1998 by experts working for several years in regulatory affairs at Boehringer Mannheim dealing with complex drug registrations in the commercial environment. The idea to support the pharmaceutical industry in drug registration met with instant success, and as registration procedures have become increasingly complex PharmaLex has grown into a dynamic and successful company.
Today PharmaLex is one of the largest companies offering worldwide drug registration services, and has successfully compiled registration dossiers in more than 100 countries.
PharmaLex International is to participate at the EU Marketing Authorisation - Update on Generics, Variations and eCTD Forum, which will take place in Sofia, Bulgaria, on 11 and 12 May this year. The schedule is as follows. Day one: 11 May 2010 Generics: full applic