Akhilesh Nagaich, PhD

Energizer
DISC Type : I

Director of Regulatory Affairs (Head CMC) at Kashiv BioSciences LLC

Washington DC-Baltimore Area, United States

Overview

Dr. Akhilesh Nagaich is a Regulatory and CMC Executive and the Founder of FDAInsight, LLC. Leveraging over 20 years of experience, including a past role as an FDA Principal Investigator, he advises biopharma companies on complex regulatory submissions, CMC development, and GMP compliance. He holds a Ph. D. from the University of Allahabad.

His work includes serving as an expert witness in high-stakes pharmaceutical litigation involving patents and regulatory compliance. His deep scientific background is demonstrated through publications on gene expression, epigenetics, and the molecular structure of DNA.

Personality Overview

Informal

Big Picture Person

Full Of Energy

They are always positive and upbeat, so take their promises with a pinch of salt.  They are friendly, approachable and love to make new connections. Unlike C or D types, they are vocal with their opinions but not so much with their questions.

Topics They Care About

Regulatory Strategy
He advises biopharma and life sciences organizations on FDA regulatory pathways, including IND, NDA, BLA, and ANDA submissions.
CMC & GMP Compliance
A core part of his professional focus involves Chemistry, Manufacturing, and Controls (CMC) development and ensuring Good Manufacturing Practice (GMP) compliance.
Litigation Support
He serves as an expert witness in pharmaceutical cases, providing technical testimony on FDA regulations, patents, and industry practices.

Media Appearances

Akhilesh has no verified media appearances

Work History

12-2018 - 11-2019
Director of Regulatory Affairs (Head CMC) at Kashiv BioSciences LLC
9-2017 - 10-2018
Senior Manager Regulatory Affairs at Emergent BioSolutions
2017
Founder and Principal Consultant at FDAInsight, LLC
4-2015 - 8-2017
Senior Industry Consultant at The FDA Group, LLC
4-2015 - 7-2015
Regulatory Affairs Manager at Medefil, Inc.

Education

Ph.D from University of Allahabad

More Information

Social Presence :

Prographics :

Exp : 14 Location : Washington DC-Baltimore Area, United States Job Level : Leadership Designation : Director of Regulatory Affairs (Head CMC) at Kashiv BioSciences LLC
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Insights For Selling To Akhilesh

During A Call Or A Meeting

DO's

  • Use phrases like ‘people will love’, ‘massive impact’ etc.
  • Share some stories about how you you have helped people in similar positions succeed
  • Invite them for a lunch or a drink/coffee

DONT's

  • Avoid ifs and buts, don’t talk too much about the risks etc.
  • Avoid overloading them with too much detail
  • Don’t be too formal, focus on building comfort and trust

When Cold Calling

When Writing An Email

While Negotiating & Closing

    The secret to closing fast with Akhilesh is

  • Relationship and rapport can play an important role, sometimes more than the other factors.
  • Will you ever get a clear answer from Akhilesh

  • They will probably never say no directly, you have to make that decision yourself.

Insights For Deal Planning

    How fast (or slow) will Akhilesh move?

  • They are not the quickest decision makers, their friendly attitude could be misleading.
  • Can Akhilesh take some risk or not?

  • They can accept limited risks, ones that they think will not impact them personally.

You And Akhilesh

Personality Compatibility


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