Practical Regulatory Support for Your Next Milestone

Regulatory Strategy

Development-aligned regulatory pathways, evidence-gap assessments, and milestone planning.

CMC and Submission Readiness

CMC planning, submission coordination, and document preparation and review within an agreed scope.

Agency Meeting Support

Focused questions, clear briefing materials, and team preparation for productive health authority interactions.

Fractional Leadership

Senior regulatory guidance, cross-functional coordination, and execution oversight tailored to your team.

Dr. Sita Somara, PhD, MBA

Principal Global Regulatory Consultant


I bring more than 20 years of drug development experience, including over 15 years of regulatory leadership across pharmaceuticals, biologics, vaccines, and advanced therapies.


I combine scientific expertise, regulatory strategy, and business insight to help teams address CMC challenges, prepare submissions, and navigate health authority interactions—from early development through marketing application readiness.


You work directly with me for practical guidance, clear communication, and support tailored to your next milestone.

More about Me and My Passion

Consulting Overview

Confident Development

I help biotechnology and pharmaceutical teams navigate regulatory and CMC challenges—from early development through marketing application readiness.


Through focused assessments, submission planning, health authority meeting preparation, and fractional regulatory leadership, I turn complex requirements into practical next steps.

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AI-Assisted Workflow, Expert Review

Where appropriate, I use AI-assisted workflows to organize information, support document preparation, and flag potential inconsistencies. I review outputs against source materials and apply scientific and regulatory judgment before delivery.


Client information is used only within agreed tools and data-handling arrangements. The benefit of AI-assisted support depends on the task, source quality, and review requirements.


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Product Expertise

Biologics & Vaccines

Pharmaceuticals

Cell, Gene and Tissue-Based Therapies

Combination Products