consultancy specialized in regulatory affairs
The drug approval process in Spain is complex and requires strict compliance with current regulations. Our services include:
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- Regulatory strategy for medicines: we develop regulatory strategies that are aligned with the guidelines of the Spanish Agency for Medicines and Health Products (AEMPS) and European regulations, to facilitate marketing authorization.
- Pre and post-sale product management: leaflet, technical data sheet, packaging, etc.
- Development of the regulatory dossier: we advise on the preparation and submission of the dossier required for marketing authorization, ensuring that it meets the required scientific and technical standards.
- Registration and licensing of medicines: we manage the registration of medicines with the AEMPS, including the obtaining of marketing licenses and the management of decentralized or centralized procedures.
- Post-Authorization and Surveillance: we provide ongoing support for variation, renewal and pharmacovigilance management, ensuring regulatory compliance throughout the drug’s lifecycle.
- Management of educational and promotional materials.
- Drug safety management.
