Regulatory Affairs can offer a professional evaluation of regulatory procedures for your APIs and pharmaceutical Specialities to achieve best possible registration outcome.
Project Management
- Project identification, planning, monitoring
- Assistance for audits (preparation and support)
- Analyses of product and company acquisitions and licensing opportunities
Regulatory Affairs
- Expert review and regulatory gap analysis
- Dossier analysis and validation
- Assistance in preparation
- Review of product development
(pharmaceutical, toxicological and clinical aspects)
Documents & MAAs Procedures
- CTD Formats, DMF and CEP procedures
- MAAs via national, decentralized (MRP & DCP) and Centralized EU procedures
Network
- Submission applications to regulatory authorities, communications and follow up
- Agents in leading pharmaceutical regions
Therapicon® is a registered trade-mark in Italy and at OMPI (WIPO)-Geneva