REGULATORY UNIT
 REGULATORY UNIT

The main strenghts of a Swiss registration are: - The Swiss authority requires only 7 months for approval - The Swiss pharmaceutical market is over CHf 4,3 billion per year which means approximately CHf 600.—per person

SERVICES

• Submission in Switzerland

• Support in solving specific registration   problems

• Reviewing and evaluation of the   documentation, check of completeness and   assessment of suitability for registration,   provision of a list of missing items or   deficiency reports if necessary, detailed cost   estimate (budget) with deadlines
 
• Amendments and completion of the   documentation in compliance with the   requirements and guidelines of the Swiss   authority. I.P.A.S. can assume the   responsibility for the production of   pharmaceutical, pharmacological and   clinical expert reports (in collaboration with   internal and external experts in the various   fields), patient information leaflet and letter   of application. I.P.A.S. handles the   administrative formalities for application   and preparation of draft packaging in   Germany, France and Italy

• In addition, I.P.A.S. gives support in   renewal of registrations and revision   procedures.
 
© 2010 I.P.A.S. - Institute for Pharmacokinetic and Analytical Studies  Partita IVA n° 296 932





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