Efficient development, successful approval?
Drug Device combination with leading medicinal product?
Find out about Article 117, MDR and how to address the Medical Device part in the dossier; join our webinar!
Experience with ATMPs/biologicals and ready to define strategy and obtain (IND, IMPD, MAA, BLA, variations) approvals ?
Acting as local safety and pharmacovigilance representative for MAH products in the Benelux?
Development and life cycle strategy, MDR, ISO standards, QMS, technical documentation?