RECENT PROJECTS

EXAMPLES OF COMPLETED PROJECTS

Regulatory leadership and strategic consulting multiple US INDs, Clinical trial applications (European Union, Canada)
Strategic advisor for EOP2/Pre-Phase 3 meetings with US FDA for immuno-oncology program
US Agent and FDA strategy advisor for small molecule based therapeutic through NADA (veterinary) submission, approval, and post-approval change management
Interim Head of Regulatory Affairs to support transition in regulatory leadership at mid-size biotechnology firm
Full-service IND filing for Oncology product
Regulatory affairs and regulatory operations support for NDA filing for drug-device combination product
Regulatory lead, acting FDA liaison and/or US agent services for several biotechnology companies
Regulatory strategy advice and regulatory due diligence for a biosimilar product
Acting Head of Regulatory Affairs for a biotechnology company developing biosimilars
Regulatory support Global Phase 3 Clinical Program at a Top 10, Fortune 500, and Global Pharma
Successful Pre-IND meeting and Scientific advice meetings for a Biotechnology company developing combination products
Pre-NDA meetings (CMC, Clinical), successful NDA filing for a controlled release product
End of Phase 2 (EOP2) Meeting with FDA’s Division of Anesthesia, Analgesia, and Rheumatology for a Controlled Release Pain Product for a Biotechnology Company
Multiple US INDs, Clinical trial applications (EU, Canada)

Additional project summaries available upon request

Elaine Stracker

General Counsel & SVP Corp Development
Maky Zanganeh & Associates

Pre-IND to First-In Human

We developed a great working partnership with Deepa Deshpande, founder of Universal Regulatory Inc. Deepa’s dedication to our project was quickly evident. She successfully and in record time assisted us in getting IND approval for a critical program, and also managed our ex-US regulatory matters. Deepa is extremely knowledgeable about regulatory laws in US and ex-US and a highly competent professional. Her ability to strategize, pay attention to detail, and creatively address regulatory issues, made her a highly valued member of our team. She will do what is necessary to get the project done and on time! We were fortunate to have her working with us and strongly recommend her.