Decentralised Procedure Process Timetable
We have summarized all DCP steps in this flow chart for you to download and keep always at hand.
Asphalion provides reliable support for all types of regulatory procedures and submissions within EU, UK, US and many other regions. We have over 20 years of track record with New Chemical Entities, Biologicals, ATMPs, Orphan Drugs, Generics, OTCs, Herbal Medicines, Homeopathic Medicinal Products, Medical Devices and Food Supplements. We coordinate your submissions, liaise with agencies and solve all potential hurdles, making sure to comply with critical timelines and reducing the time to market. We offer flexible options for support in the submission process, including submission planning, coordination and execution.
Asphalion provides reliable support for all types of regulatory procedures and submissions within EU, UK, US and many other regions. We have over 20 years of track record with New Chemical Entities, Biologicals, ATMPs, Orphan Drugs, Generics, OTCs, Herbal Medicines, Homeopathic Medicinal Products, Medical Devices and Food Supplements. We coordinate your submissions, liaise with agencies and solve all potential hurdles, making sure to comply with critical timelines and reducing the time to market. We offer flexible options for support in the submission process, including submission planning, coordination and execution.
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Why Asphalion?
Adaptation to specific regulations and dealing with the Health Authorities can be complex. Whether you are working towards a FDA, EMA or any other regulatory submission, Asphalion can provide its expertise and support for a successful registration process.
Having participated in 18 Centralized Procedures, many DCPs and MRPs involving all European Agencies, more than 30 FDA projects and global roll-outs in emerging markets, our experience keeps growing every day.
We also have extensive experience with the management of translations for regulatory submissions processes, especially for Centralized Procedures (from pre-opinion, until linguistic review and opinion by agencies), in which time and accuracy are critical. We can provide support in managing all required activities and processes where you need expert guidance.
Main benefits
Related Resources
We have summarized all DCP steps in this flow chart for you to download and keep always at hand.
The Access consortium is a medium-sized coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the UK that work together to promote greater regulatory collaboration and alignment of regulatory requirements.
In this business case about an Asphalion eSubmission NDA, a Swiss Pharmaceutical company needed assistance with an initial complete NDA application, including datasets and SPL.
Asphalion contributions to the fight against COVID-19
(CTR) No 536/2014
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other regions.
A case study about Marketing Authorization Expansion in Europe. A small European
Pharmaceutical company with
local activity in its country, with a
growth strategy aiming to
expand to international
markets but lacking experience
and capability in managing
complex EU procedures.
Ready to equip yourself with first-hand information from our experts? Join us in our new free webinar, “Clinical Trials transition to CTR/CTIS”. All ongoing clinical trials in the EU must
During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.
Have a look at this Business Case where Asphalion provided a leading global pharmaceutical company with full regulatory support for the management of Policy 0070 for a new active substance
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