The major success factors to achieve EU pharmaceutical product registration for Indian pharmaceutical products
Monday, 18. May 2009The Indian pharmaceutical industry has made great progress and moved up the value chain from generics to discovery-based R&D. Time and budgetary constraints urge Indian pharmaceutical companies to look for smart approaches to find the right development and registration processes for their products and achieve key milestones fast.
FOCUS has many years of practical experience with national submissions, European centralized and mutual recognition procedures. Most importantly FOCUS has developed a special expertise in bridging studies.
FOCUS offers this competence as service package for product development and product authorizations in the European Union and Switzerland. FOCUS wants to assist the Indian pharmaceutical in capitalizing on the unique business opportunity of developing new products, bridging India to Europe and major western markets.
In particular, FOCUS offers regulatory pathfinding for Indian clients to define the best development and regulatory strategy and prepare the appropriate documents for registration. One particular strength is FOCUS’ international staff that comprises German and Indian drug development experts who are familiar with both industry cultures.
Our experts have compiled some useful information regarding „The major success factors to achieve EU pharmaceutical product registration for Indian pharmaceutical products“.
You may wish to order your complimentary copy by contacting Dr. Maikel Raghoebar (Director Clinical Pharmacology) via maikel.raghoebar [at] focus-cdd.de.
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