Mergers & Acquisitions

Your Beacon through M&A in FDA Regulated Waters

Compliance Considerations

Looking our for false billings, physician kickbacks, fraudulent marketing, seeding trials and more…

Privacy Considerations

Reviewing processes for the transfer of sensitive patient data and proprietary information

FDA Considerations

Ensuring regulatory compliance, mitigating risk, and solidifying the value proposition of the merger or acquisition within the tightly controlled health and life sciences industries.

Compliance and Value

Compliance and Regulatory Solutions for Business Growth

Substandard M&A decisions can result in contractual claims, administrative penalties, civil payouts, and/or criminal sanctions against individuals and companies.


These decisions may be based not only on FDA related misconduct issues (which have led to billions of dollars in fines and penalties, jail time and career ending sanctions) but also FTC considerations like privacy and DOJ concerns like compliance.


Recent compliance updates from the Criminal Division of the Department of Justice as they pertain to M&A activity have multiplied the problems that companies may face.

Why Us?

Our Principal Attorney, Darshan Kulkarni, understands the complex regulatory landscape governing pharmaceuticals, biotechnology, medical devices, foods and healthcare technologies. He also understands the evolving compliance, and privacy needs that affect these M&A transactions.


The Kulkarni Law Firm empowers life science companies achieve their strategic objectives by conducting due diligence, negotiating contracts, and advising on regulatory matters. We deliver tailored and innovative solutions that propel businesses forward.

Our Process is The Key to Your Success

  1. Define Scope

  2. Create Due Deligence List

  3. Review Documentation

  4. Summary Report

  5. Contract Development

  6. Post Merger Integration

What We Offer

Legal and Compliance Due-Deligence

Drafting and Negotiating Agreements

Voluntary Self Disclosures

Regulatory and Compliance Risk Assessment

Closing and Integration Support

Confidentiality and Non-Disclosure Agreements

Government Approvals and Notifications

Privacy Considerations

Regulatory Due-Diligence


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