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.