Latest Communications

19 March 2012
Nautlius Neurosciences, Inc. Announces a New Approval for CAMBIA® in the Acute Treatment of Migraine

01 March 2012
APR Applied Pharma Research ("APR") and Labtec GmbH ("Labtec") announce the European approval of Zolmitriptan Oral Dispersible Film (ODF)

18 January 2012
APR Applied Pharma Research s.a. (“APR”), Labtec GmbH (“Labtec”) and Norgine BV (“Norgine”) announce the signature of an exclusive licensing agreement under which Norgine will market and distribute Setofilm™ Ondansetron Oral Dispersible Film (“ODF”), in Europe and selected non-European countries.


topical

TOPICAL MEDICAL DEVICE

Project Design Planning



REGULATORY STRATEGY

The first step of the project Design Planning is the valuation of the best Regulatory Strategy according to costumer requirements. An accurate classification study according to the 93/42/EEC Directive (or equivalent 510K in the US) and related amendments is necessary. If needed, APR is able to manage a Scientific Advice meetings with the Notifying Body or Health Authority in either EU and US.



SELECTION OF THE BEST DELIVERY SYSTEM

Where the main component/s is/are defined, APR can make the most of its/their chemical/physical characteristics to determine the most suitable galenic approach and to develop the best form for the intended topical device.



INVESTMENT PLAN

This is the last Step of the project Design Planning: APR is able to provide a complete Development Plan including activities, time and costs.


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