MEDICINES

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.
© Trinity Solutions S.L. - C/ Rodriguez Marín, 88 - 2º B · Madrid - (+34) 91 457 48 03
Follow Us facebook