IWA Consulting ApS We offer a complete portfolio of regulatory affairs and medical affairs services to support the successful development and timely registration of human and veterinary medicines including – originators, generics as well as biotech products. With a strong track record for delivering excellent results in regulatory affairs to our clients, we focus on completing tasks with high quality in a timely and cost efficient manner. We collaborate worldwide and specialise in the European and the US markets, interpreting legislation and guidelines, and acting as liason with competent authorities to ensure an application is prepared in the required standard, acceptable for each health authority and completed to meet approval. Our Procedure Management group provides guidance and regulatory strategies. We prepare and run all types of Marketing Authorisation procedures incl. handling of deficiency letters during procedure/variation; and managing the finalization of the procedure/variation and the national phase after the initial MA procedure. This includes National Procedures, MRPs, DCPs and CPs. We also provide support and management for maintenance of already approved products including: variations, renewals, MA-transfers and withdrawals. During the past three years the Procedure Management group has run more than 100 EU MA-procedures. With a strong focus on electronic handling of all tasks we provide service in establishing document management systems also to support eCTD/eNtA/eIND submissions. Document management includes eCTD granularity structure and templates. eCTD submission preparation is offered to our clients from our in-house service. Since 2007 we have prepared over 1200 eCTD sequences including registration procedures, variations, MA-transfer and renewals. Our Regulatory Affairs Development and Support group takes care of M2-5 documentation (review, writing etc), early stage development strategy consultancy, documentation, preparation of scientific advice and health authority meetings. They also prepare Product Information texts (Core EN versions as well as national texts), CCSI/CCDS, PIP applications, orphan drug designation requests, CTA- and IND applications as well as SME applications. We offer Project management including developing overall product/project development plans including budget, timeline and activity plan as well as due diligence adhered hereto. We are represented via a network of local contacts in all EU countries which ensures us easy and reliable collaboration as well as direct contact to NCAs where needed. If you need Regulatory Affairs or eCTD filing expertice, contact us.