Regulatory Procedures

Systematic management of regulatory procedures for optimized time to market

Regulatory Procedures

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.

Our Solutions

  • Assessment of regional requirements (Module 1 for new MAA and registration procedures)
  • Support and management of new Marketing Authorization Application submissions to comply with critical timelines
  • Centralized Procedures (CP) in EMA
  • Decentralized 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 authorization
  • National Procedures, including Fast-Track procedure
  • FDA procedures (IND, NDA, BLA, ANDA)
  • Global roll-out in emerging markets
  • Reliable coordination of local partners for global registration procedures (ROW)
  • Management of labelling
  • Promotional material review
  • Translations

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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

  • Specialized expertise in Regulatory submissions
  • Global procedure management
  • Reduce time to market
Carme Ulla - Asphalion
Carme Ulla
Regulatory Affairs Director
“Our expertise will anticipate any issues or challenges that could arise and will ensure you are prepared to overcome them”

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