TIARE CONSULTING S.L. offers the following regulatory services to pharmaceutical laboratories and technical support required for:
- Readability test.
- Dossiers in eCTD format.
- Non-clinical Writing.
- Clinical Writing.
- Renewal of marketing authorisation.
- PSURs.
- Pharmacovigilance management.
- Variations of medical products (type IA, IB or II).
- Review and preparation a drug dossier.
- Registration of TAC.
- Transfer of drug dossiers.
- Contact with Regulatory Authorities at national and international level.
- Preparation and presentation of Drug Master File (DMF).
- Management and CEP application.
- Review labelling, summary of product characteristics and package leaflet.
- Change of Technical Director.
- Request for national codes.
- Review advertising of medical products.
