Developing compliance intelligence requires technical knowledge and experience but also timely awareness of harmonization trends. Harmonization of regulatory requirements between the USA, EU, Canada and others, addressed by the Global Harmonization Task Force (GHTF), aids companies in setting global compliance objectives. While harmonization does not result in 'identical' requirements the similarity is sufficient to build a base of compliance intelligence that can be consistently applied where necessary. The need to develop complete separate sets of dossiers of compliance documents is becoming less acute.
QNET LLC 'Doing it Once!' consulting services assist with the development of a manufacturers base of compliance intelligence for the EU, USA and Canada. QNET's team of regulatory affairs professionals has the technical knowledge, performance and results record to assist with USA-FDA Requirements, EU Medical and In-Vitro Diagnostic Directives and Health Canada's Medical Device Program.