Kulkarni Lawyers

About Us

* Former Pharma Corporate Counsel

* Experienced Corporate QA

* Experienced Clinical Trial Negotiator

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Contract Trial Negotiations

* Trial Agreements and Budgets

* Trial Amendments

* Facility Letters

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Regulatory Services

* ANDA application registration

* State pharmacy licensure registrations

* DEA license

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Life Cycle Management

* Hatch Waxman Litigation planning

* Orange book review services

* Patent Disclosure Form

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Applications

* Licensing and Applications

* Pharmaceutical

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Pharmaceutical Outsourcing

* Employee agreements

* Contractor Agreements

* Drafting and filing public releases

* Service Agreements

* Supply

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SMOs

* Respond to FDA 483s

* Formulating quality SOPs

* SOPs Regulatory and Quality

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Litigation Services

* ANDA litigation assistance

* Orange book review

* Disclosure Form

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About Us

* Former Pharma Corporate Counsel * Experienced Corporate QA * Experienced Cli...

Contract Trial Negotiations

* Trial Agreements and Budgets * Trial Amendments * Facility Letters ...

Regulatory Services

* ANDA application registration * State pharmacy licensure registrations * DEA ...

Life Cycle Management

* Hatch Waxman Litigation planning * Orange book review services * Patent Dis...

Applications

* Licensing and Applications * Pharmaceutical Licensing...

Pharmaceutical Outsourcing

* Employee agreements * Contractor Agreements * Drafting and filing public relea...

SMOs

* Respond to FDA 483s * Formulating quality SOPs * SOPs Regulatory and Quality...

Litigation Services

* ANDA litigation assistance * Orange book review * Disclosure Form completion...

Firm Overview

The Kulkarni Firm leverages its experience in pharmaceuticals, biopharmaceuticals and medical devices to provide optimal solutions to pharmaceutical companies and Clinical Trial Investigators. Having worked with small, medium and large sized providers the Firm's Principal Attorney can understand your questions and concerns and can propose solutions that are right for your company.