PharmaLex GmbH
- Tel: +49 621 1815 3810
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PharmaLex International provides specialized support for world-wide rapid and uncomplicated drug registration.
Depending upon the specific requirements, PharmaLex's highly qualified registration experts can assist in all areas, evaluate the documents in view of current guidelines, compile complete electronic dossiers, and manage the entire process. Our expertise includes medicinal products: NCEs, generics, biotechnological products and medical devices, food supplements, cosmetics.
PharmaLex international can manage either parts or the whole of your registration process: Mutual Recognition Procedures (MRP, DCP), National registrations, Centralised Procedures (CP), DMF and CEP processes, CTAs, Variations and Renewals. For EU registrations PharmaLex's network of local offices ensure trouble-free registrations.
Contact:
Joseph-Meyer-Strasse, 13-15
D 68167
Mannheim
Germany
Tel: +49 621 1815 3810
Fax: +49 621 1815 3820
Website: www.pharmalex.de
REACH Legislative Projects
- REACH Legislative Projects »
One of the most ambitious legislative projects in the history of the European Union will come into force in June 2007: the complete realignment of the EU chemical legislation.
Electronic Common Technical Document - eCTD
- Electronic Common Technical Document - eCTD »
Processing and managing the increasing amount of submission documentation has been a demanding task ever since the establishment of drug regulatory legislation.
Paediatric Medicinal Products
- Paediatric Medicinal Products »
Adequate medicinal therapy on the basis of medicinal products for the use in children is a challenge – not only for paediatrics.
Medical Device Market
- The importance of the medical device market is growing in Europe. »
The possibility to access the whole European Economic Area (EEA) market by means of a single registration procedure is given by CE marking. Currently the European directive on medical devices is being updated.
Pharmaceutical News
- Pharmacovigilance & Risk Management: Outsourcing to Experts »
Until recently, the imagination of outsourcing of pharmacovigilance responsibilities and activities fell far behind the comfort zone of responsible pharmaceutical managers, as drug safety has traditionally been an independent, self-contained function in most pharmaceutical companies.
Worldwide Drug Registration
- The Relaxed Route to Worldwide Drug Registration »
Every day PharmaLex experiences what it means to bring a medicine onto the market. Innovation, ideas, hard work, persistence and patience, as well as strategy, coordination and interdisciplinary thinking is what is needed to get a new product through research and development.
