Consultancy
The advent of the "virtually integrated life science company" has accelerated the requirement for independent and objective consultants with the ability to provide integrated advice which impacts decision making processes. In addition, consultants need to be reliable, available on demand and only when required. Kinesis Pharma meets this challenge by delivering all the drug development expertise innovative sponsors require in an accessible, flexible and pragmatic way which cannot be matched by independent consultants or full-time employees (FTEs).
Drug development consultants at Kinesis Pharma leverage their significant experience and proven expertise to provide technical consultancy with strategic and regulatory relevance. This process starts in anticipation of drug candidate selection, when a first target product profile is carved out to form the basis for strategic drug development planning. Strategic drug development planning is undertaken by technical and regulatory consultants to provide an integrated drug development plan, the "road map" of development and registration.
Drug development consultants provide advice relevant to their area of expertise (e.g. CMC, non-clinical and clinical) and are employed in different roles from technical experts and representatives on drug development teams to technical due diligence activities.
Regulatory and quality consultants form an important part in drug development consultancy. On the one hand, regulatory consultants determine regulatory strategy and manage interactions with regulatory authorities and regulatory submissions. On the other hand, quality consultants align quality with the relevant good practise guidelines and phase of development thereby ensuring compliance.
"Advice which gives direction to decision makers"
Contact detailsJohan teKoppele, Ph.D.Chief Operating and Scientific Officer Tel: + 31 76 54 80 671 Mob: +31 6 44 53 86 37 Email: Johan.teKoppele@Kinesis-Pharma.com |
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