| Altiex Life
|| Pharmaceutical field
|| Liven up your projects
Altiex Life provides expert regulatory affairs, pharmacovigilance and clinical services to pharmaceutical companies around the globe.
Altiex Life is headquartered in Prague, Czech Republic, and their operations are based in Czech Republic, Spain and Italy. The company has a professional staff from different countries and languages in order to provide a personalized attention to their customers.
| Regulatory Affairs
|| Readability Tests
|| Clinical Services
- Regulatory strategies according client needs.
- Full submission management: Preparation of MAA for National procedures, MRP/DCP. We assist you in all steps of the procedures.
- Representation in national step (DCP/MRP).
- Dossier conversion into eCTD format (trough Extedo eCTD manager).
- Registration in countries outside European Union.
- Medical writing (Non-clinical and Clinical overviews and Summaries).
- Audits of dossier documentation.
- AP DMF review.
- Due Diligence evaluation.
- Post marketing authorization services: variations, renewals, licenses, fast track applications, transfers, and others.
- Compilation and preparation of SmPC, PIL and labeling according current EU requirements and guidelines.
- Act as MAH.
- Artworks designs.
- PIL revision and update to current QRD Template and local legislation
- Mock-up creation
- Design of protocol and questionnaire
- Three rounds of testing and preparation of the final report
- Provision of full Pharmacovigilance System.
- Qualified person for PV in Europe (EU QPPV), Deputy QPPV and local QP representatives in each European country (if required).
- Pharmacovigilance System Master File (PSMF) and PSMF summary writing.
- Risk Management Plans (RMP).
- Eudravigilance registration/support.
- Extended Medicinal Product Dictionary (XEVMPD) submission.
- Literature searches and database consulting (global and local).
- Periodic Safety Updates Reports (PSUR).
- Standard operating procedures (SOPs).
- Individual case safety report (ICSR) processing and follow-up. Collection, medical review, quality check, submission, documentation and archiving.
- Expedite reporting in accordance with regulatory requirements.
- Setup of electronic reporting with an EU agency (preparation of cases and full testing).
- Clinical monitoring (site qualification, study initiation, routine monitoring, and close-out visits) at investigational sites for GCP, applicable legislation and client SOP/guidelines compliance.
- Investigational sites recruitment and study budget negotiation.
- Collection and quality assurance of clinical trial essential documents.
- Submission of essential documents to Ethics Committees.
- Draft protocol review and project feasibility.
- Project management reports preparation.
- CRFs and/or clinical data review and verification, queries utilization.
- Site management and on site/in house queries resolution.
- Development and maintenance of relationship with investigational sites and client company.
- Safeguard of patient safety and adherence to the protocol.
- Continuous clinical tracking system review and updates.
- Altiex Life offers prompt scientific-medical translation services of high quality from/into languages of the European languages + all major languages.
- Pharma specialized, editing, proof-reading.
- Performed by the native expert linguist.
- Marketing translations
- ↑ http://www.altiex.com/