Regulatory Procedures and Submissions services

April 20, 2022

Asphalion can provide you with reliable support for all types of regulatory procedures and submissions in EU, UK, US and many other regions. We have 20+ years of track record with New Chemical Entities, Biologicals, ATMPs, Orphan Drugs, Generics, OTCs, Herbal Medicines, among others. We can 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.

These are the main services we can provide you with:

– Assessment of regional requirements (Module 1 for new Marketing Authorisation Applications (MAA) and registration procedures: preparation of documentation in national language, support in any specific national regulation, contact with national authorities if needed, regulatory submissions, adaptation of core package to national requirements/forms/regulations, etc.)

– Support and management of new MAA submissions to comply with critical timelines

– Centralised Procedures (CP) in EMA

–  Decentralised Procedures (DCP) and MRPs (Mutual Recognition Procedures) with all European Agencies, including support for National Phases for product information translations, mock-up review, follow-up with advisors until authorisation

– National Procedures

– FDA procedures (IND, NDA, BLA, ANDA)

– Global roll-out in emerging markets

– Coordination of reliable local partners for global registration procedures (ROW)

– Life-cycle management of labelling and artworks

– Promotional materials (submission to national competent authority, support in material preparation according to national requirements, proof-reading, regulatory and medical validation, etc.)

– Management of Translations

 

For further information you can contact us at: info@asphalion.com 

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