Global Regulatory Submissions

We provide reliable support for all types of regulatory procedures and all types of dossiers. We coordinate your submissions, liaise with agencies, and resolve all potential hurdles.

Many of our regulatory experts have decades of experience in these activities, making Asphalion your partner of choice for all regulatory processes. We have experience in all European countries, in the US, in Canada, LATAM countries and increasing coverage of RoW countries.

How We Support You in Global Regulatory Submissions

With 20 years’ track record in handling submissions, we have gained experience in the compilation of almost all types of submission dossiers: New Chemical Entities, Biologicals and Advanced Therapy Medicinal Products, Orphan Drugs, Generics, OTCs, Herbal Medicines, Homeopathic Medicinal Products, Veterinary Medicinal Products, Medical Devices, Cosmetics and Food Supplements.

Regulatory Submission Processes in which We Specialize

• Assessment of regional requirements
• Support and Management of new marketing authorization submissions to comply with critical timelines
• Centralized Procedures (CP) in EMA
• Decentralised Procedures (DCP) with all European Agencies and National Phases (NP)
• FDA projects (IND, NDA, BLA, ANDA)
• Global roll-out in emerging markets
• Reliable coordination of local partners for global registration procedures (RoW)

Translation Management for Centralised Procedures​

We have extensive experience with the management of translations for regulatory submissions process. Especially for Centralised Procedures, in which time and accuracy is critical, we can support you to manage all required activities and processes where you need expert guidance.​

In EU Centralised Procedures we manage translations from pre-opinion, until linguistic review and opinion by agencies.

Also for maintenance activities, we can organize to manage the translations in all EU languages. We can check the national translations internally, with the customer / affiliates and/or our dedicated translation service provider.

We update all necessary texts and coordinate the communication with National Agencies and affiliates, if required to ensure the success of the centralised procedure.​

Our preferred translation provider has been audited and approved for use within our ISO validated quality system.