Facts

Own-developed process for CP including:

– 25 translations acc. to ISO DIN 17100 & 9100
– QRD, EDQM, medDRA and Pharmacopoeia compliance
– Product related terminology
– Last changes by CHMP at Day 210
– Support by Linguistic Review by MS after submission.
– Annex A
– Project Support 24/7
– Cost AirBag