regulatory affairs unit 5 documents biotechnology development process advanced therapy hybridoma and mab methods extrapolation carcinogenicity immunogenicity approval process eu regulatory framework eu species selection biologicals approval eu eu centralized procedure biological substance biological medicines maa investigational medicinal prod biologicals unit 3 eu biosimilars rahb china medical device china unit-5 mra203t ramd scientific literature lower-risk medical devices product life-cycle process inspection quality management chinese gmp iso 13485 medical device classification investigation medical devic clinical evaluation quality system requirements regulatory registration china classification medical device cfda nmpa medical devices commission on dietary suppleme withdrawal of the regulations new dietary ingredients information labeling labeling and nutrition burden of proof on fda aim of dshea 13 sections false claims 1994 misbranded adulterated ffdca fda dshea mra204t usa dshea dietary supplement dshea rafn minor & major variation user free certificate halal certificate mohap & dha united arab emirates stability requirements gcc ectd saudi arabia and uae abridged procedure denr registration process arabstate sfda arabia states & uae post approval requirements gcc regulatory requirements gcc radc uae saudi arabia gcc state licensing resposibility cdsco functions/ responsibilit cdsco organisation chart state licensing authority sta cdsco convention application ordinary or non-provisional provisional application novel invention intellectual rights properitary rights india mra104t industrial application inventive step novelty types of patent forms for patent advantage of patent ipr trademark copyrights patent risk regulatory writting segments drug risk evaluation drug development marketing product drug risk evaluation introduction to epdb epdb approaches drw drug substance drug product doc pharmaceutical industry mra102t epdb animal care survillance qurantine stabilize animal procurement veterinary care v rationale guideline unit 3 money mice disadvantage of animal testing advantage animal testing animal study cpcsea application form country and animal welfare animal welfare rationale animal study animal testing cpcsea guideline conducting clinical trial manufacturing import bioequivalance bioavailability pms study in special population application for permission amendments schedule y rules under schedule y schedule under d and c act crr schedule y specific requirement warehouses premises quality system gdp ema gdp usfda returen complaint distribution self inspection personnel gdp requirement gdp principle world wide grp legal requirement gdp ra
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