MEDICINES

We offer consulting services that comprise continuity over time and strategies to comply with local regulations. We have qualified personal to perform the following activities:  

• Positioning strategies and selection of registration procedure (National, Mutual Recognitiona/Descentralized procedures).
• New product registration. New applications following current requirements (Nees /eCTD).
• Update of registration dossiers. Application and monitoring of variations (Nees o eCTD). Product Information, Expert reports. Readability tests in Patient Leaflets.
• Maintenance of registrations. Annual Interest of commercialization. Management of IT authorities’ tools.
• Advertising control and compliance.
• Active Substance Master Files (ASMF).
• Contacts with Spanish authorities: Spanish Medicines Agency, Ministry of Health and regional/local health authorities.
• Price and Reimbursement request in Ministry of Health. Pharmacoeconomic studies.
• Pharmacovigilance: Pharmac ovigilance Master File and Procedures.