Regulatory Affairs
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Regulatory Affairs

VCRO offers precise, up-to-date and comprehensive regulatory services to help our clients meeting development and registration objectives.

Regulatory Affairs (RA) Team within VCRO offers a wide spectrum of regulatory services covers IND to NDA/BLA for new drugs, device, and combinational product. We can be a professional regulatory consultant for our clients, guiding the development and registration strategy from authority’s point of view, alone with integrating multiple countries’ regulatory requirements to form the most efficient plan. We can also be our clients’ best resource in executing tedious and sophisticated regulatory procedures which require high level of accuracy and precision. Apart from all technical strengths and decades of experiences accumulated within VCRO, maintaining smooth communications and growing mutual trusts with health authorities are particular critical values that VCRO’s RA team can benefit our clients in terms of accelerating regulatory procedures.

VCRO RA services to be applied to the US and Taiwan:

  • Regulatory consultation service
  • Regulatory consultation meeting service
Dossier preparations, compiling, submission, management of review procedures for:

 

  • Clinical trial (for health authority and IRB/IEC)
  • Investigational New Drug (IND) (CTD, eCTD, traditional)
  • New Drug Application (NDA) (CTD, eCTD)
  • Plant Master File (PMF)
  • Medical device product registration
  • Medical device GMP/QSD
  • Bridging study evaluation report
  • Clinical trial interim report
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