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Welcome to UniCentrix!

 

Regulatory Compliance and Regulatory Conformance

Unicentrix consultants have performed Regulatory Compliance and Regulatory Conformance for:

  • CMC
  • Product Information/ Labelling
     

New registration

Unicentrix consultants have indepth knowledge and experience with registrations in the following Global markets:

  • EU MAA
  • US NDA/ BLA
  • Canada NDS/ BLS

Other global markets covering seven geographical areas Non-EU Europe, CIS, Middle East, Africa, Latin America, South Asia, Asia Pacific and China.

Regulatory Strategy and Project Management

Wide experience in representing companies in various regions:

  • EMA (European Medicines Agency)
  • MHRA (Medicines and Healthcare products Regulatory Agency)
  • NCA (EU National Competent Authorities)

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