Alejandra Mork

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drug development counselling cmc development solutions regulatory affairs solutions clinical operations solutions clinical trial supply solutions pharmacovigilance solutions quality assurance strategic project management pharmaceutical manufacturing drug development pharmaceutical consultancy clinical trial management regulatory affairs clinical operations drug development counseling cmc development clinical trial supply pharmacovigilance project management strategic project planning therapy area expertise clinical research drug lifecycle management regulatory compliance gmp gcp clinical trial design patient safety submission documentation risk management biostatistics medical writing preclinical development phase i trials phase ii trials phase iii trials regulatory strategy insourcing outsourcing global safety database quality by design cmc project management drug quality assessment medical device regulations clinical monitoring data management eclinical systems supply chain optimization adverse event reporting periodic safety updates medical assessment safety surveillance contract manufacturing organizations impd submissions protocol assistance study-specific documents pharmaceuticals medical productivity