Our Services

Regulatory

Our regulatory teams can handle the complete trial registration and approval process. Avicemer`s Regulatory Affairs professionals are dedicated to ensuring the successful and timely submission of IND or NDA applications.

Avicemer offers support to its customers starting with the early stages providing consultancy before and after inspection by a Regulatory Authority. Regulatory approval to conduct clinical studies is a very complex process and it requires strong local expertise and network.

A partial list of the regulatory services that we provide includes:

  • Legal support for the development and registration of the clinical trial based on regulatory requirements

  • Interaction and managing meetings with regulatory agencies

  • Prepare and submit applications in accordance with regulations and guidelines

  • Clinical Trial Approval

  • Providing efficient review and approval services

  • Provide issue-focused regulatory consultation

 Our Medical Affairs services include:

  • Institutional Review Board consultation

  • Clinical development plans

  • Protocol design and development

  • Case Record Forms

  • Patient Information File and Consent form

  • Diary Cards

  • Safety Summary

  • Medical evaluation and adverse event reporting

  • Clinical and integrated reports

  • Investigator Brochure

  • Manuscripts and Publication

  • Abstract & Literature Reviews

  • Post marketing surveillance

Copyright 2004/2018

Avicemer