Aava Biomed
Regulatory and clinical medical writing for US clinical trial submissions
Aava Biomed, LLC supports sponsors through every stage of clinical and regulatory documentation, from first protocol to FDA submission.
Services
End-to-end medical writing support for clinical development programs in the United States.
Clinical trial protocols
Protocols and protocol amendments
Clinical study reports
Study reports and synopses
Informed consent forms
Clear, participant-facing consent documents
FDA submission documents
Documents for IND, NDA and BLA submissions, such as:
- Clinical summaries and overviews (CTD Module 2.5 and 2.7)
- IND annual reports and Development Safety Update Reports (DSURs)
- FDA meeting briefing documents
- Responses to FDA information requests
Review and editing
Scientific review, quality control and editing of clinical documents
About
Dr. Dikshya Bastakoty
PhD in Biomedical Sciences, Vanderbilt University
Aava Biomed, LLC is a Texas-based medical writing practice founded by Dr. Dikshya Bastakoty.
Aava Biomed handles all aspects of medical writing for US clinical trial submissions, bringing scientific depth and careful attention to regulatory requirements to every document.
Contact
For project inquiries, please email:
[email protected]