Local Support and Regulatory Affairs Service Provider in Spain

Asphalion has become a global Regulatory Affairs service provider, but we are also proud of our local expertise in Spain, which are acquired during 21 years of Asphalion’s existence.

Our 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 regulatory requirements and news.

Therefore, Asphalion is the partner of choice for local activities in Spain due to hand-on in-depth knowledge of the local regulatory requirements for pharmaceutical or medicinal procedures to be performed in the country. ​

​Our team has the advantage of being native Spanish speakers, which streamlines the communication and management of procedures with regulatory bodies such as AEMPS.​

Asphalion as Your Regulatory Affairs Services Provider in Spain​

​At Asphalion we can assist with all local activities, help to speed up approval times and unblock procedures that are in standby. Some of the regulatory procedures that we can support you with in Spain include:​

• M1 for new MAA
• National phases of DCPs and MRPs (product information translations, mockups review, follow up with assessors until authorization)
• Request of National Codes of CP products
• National submissions, including Fast Track procedure
• Management of Spanish authorities’ portals and databases (e.g. RAEFAR)
• Mandatory activities before launching
• MA Transfers
• 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
• Price increase application
• Promotional materials review according to Spanish legislation
• Compassionate use medicines management
• Clinical Trial Applications and substantial amendments in Spain
• Request of license of Pharmaceutical Establishment in Spain:
  •  Preparation of the Company Master File and SOPs
  •  Submission through the electronic portal Labofar
  •  Support in inspections
• In-house Implants
• Continuous update on changes of local requirements
• Local Qualified Person for Pharmacovigilance (local QPPv)

We understand that the procedures in another country can be complex, especially in terms of regulations and dealings with the Ministry of Health or AEMPS. Therefore, Asphalion will be happy to support you in the successful completion of all local regulatory requirements.