Asphalion has become a global Regulatory Affairs service provider, but we are also proud of our local expertise in Spain, acquired during 21 years of Asphalion’s existence. Our local regulatory affairs services span through the complete product life cycle and help customers achieve maximum local compliance. We provide regulatory affairs support from pre-submission services up to complete post-approval regulatory maintenance.
Our team of experts have extensive experience with official local Spanish entities, such as the AEMPS, the Ministry of Health, local regional authorities and the College of Pharmacists association, among others. We are fully up to date with local requirements and the latest news. We can assist with all local activities, help to speed up approval times and unblock procedures that are in standby, and provide you with reliable, tailor-made service, managing all your Regulatory activities, such as:
- National phases of DCPs and MRPs (product information translations, mockups review, follow up with assessors until authorization)
- Request of National Codes of CP products
- Management of Spanish authorities’ portals and databases (e.g., RAEFAR)
- Mandatory activities before launching
- Specific annual mandatory activities for maintenance of MA
- Local variations and renewals of National MA
- Price and reimbursement for new medicinal products and for generic products
- Promotional materials review according to Spanish legislation
- Continuous update on changes of local requirements
You can find out about other services we can provide you with in Spain here:
https://www.asphalion.com/services/local-support-in-spain/
Should you have any question, do not hesitate to contact us at: [email protected]
