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.
Regulatory Procedures Solutions
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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.
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