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.

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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.

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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

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 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