Our Team
The principles that guide our practice and commitment to our clients
Darshan Kulkarni
Founding Partner, Principal
Attorney
Expertise
Life Science Compliance, Regulatory Affairs and Legal
- Promotional Compliance: Develop, and implement promotional compliance programs, lead review committees, and counter competitor claims.
- M&A Due Diligence: Direct comprehensive scope development, due diligence investigations, findings presentations, contract customization, and post-closing integration.
- Clinical Research Compliance: Negotiate clinical trials, audit SMOs/sites, craft FDA audit responses, and represent PIs, sponsors, and CROs.
- Pharmacy Law Compliance: Aggressively represent pharmacies against state/federal agencies, PBMs, and during acquisitions.
- Manufacturing Compliance: Develop and maintain quality and compliance programs, proactively and reactively respond to FDA concerns.
- Technology Compliance: Address FDA, OIG, DOJ, OCR and other regulatory agency compliance considerations.
Experience
Former in-house counsel for multi-billion dollar PE and VC Funded Companies
Embedded Healthcare
- General counsel
- Chief compliance officer
- Chief information security officer.
Synchrogenix (a Certara company)
- VP of regulatory strategy & policy
Nostrum Pharmaceuticals
- Corporate counsel
Philadelphia College of Pharmacy
- Visiting professor
Drexel University School of Law
- Adjunct professor
Education
- Juris Doctor, School of Law Temple University
- Doctor of Pharmacy, Philadelphia College of Pharmacy
- MS in QA/RA, College of Pharmacy Temple University
- Admitted to practice law in PA/ NJ
Expertise
Chief of Indian Operations/ Indian Attorney / US Paralegal
- International Compliance and Operations: Manages FDA expectations to review promotional materials and conduct due diligence, ensuring global operations adhere to stringent standards.
- Legal Document Drafting: Draft legal agreements as they relate to clinical trials and international law.
- Client-Centric Research: Undertaking in-depth legal and regulatory research. Provides comprehensive guidance to clients, safeguarding their interests and contributing to their success.
- Digital Marketing Leadership: Directs innovative digital marketing strategies to bolster the firm’s online presence and generate leads, using analytics to refine approaches and showcase results.
- Client Engagement and Retention: Develops and executes client engagement strategies, utilizing CRM tools to enhance communication and maintain client satisfaction.
Experience
Former in-house counsel for multi-billion dollar PE and VC Funded Companies
Kulkarni Law Firm
- Chief of India Operations
- Indian Counsel
- US Paralegal
Education
- LL.B., KC Law College, Mumbai
- BS Finance, Rutgers Business School, Rutgers University
Expertise
Head of Global Marketing and Sales
- Strategic Brand Development: Shape and grow the firm’s brand to appeal to our core sectors, launching campaigns that boost our standing and stick to ethical guidelines.
- Creative Direction: Manage the creation of marketing materials, ensuring they’re on-brand and meet FDA and healthcare ad rules.
- Client Engagement and Retention: Enhance client relationships with targeted engagement efforts and CRM tools for better communication and satisfaction tracking.
- Cross-Functional Team Leadership: Guide a diverse team of marketing and design professionals, promoting teamwork and innovation within regulatory limits.
- Market Intelligence and Adaptation: Keep pace with market and regulatory shifts in our industry, adjusting strategies to stay ahead and compliant.
Expertise
Podcast and Videocast Audio and Video Design
- Multimedia Strategy: Develop and execute a strategy using podcasts and videocasts to create compelling content.
- Content Oversight: Manage the production of engaging audio and video content, ensuring alignment with our brand and strategic goals.
- Technical Innovation: Lead the technical side of content creation, keeping up with and incorporating the latest multimedia technologies and trends.
- Engagement and Growth: Use metrics to refine strategies, increasing audience engagement and expanding our reach.
Christopher Strain
Sales
Expertise
Podcast and Videocast Audio and Video Design
- Sales Strategy Development: Developing and executing sales strategies tailored to FDA regulated clients.
- Client Engagement and Retention: Building strong client relationships and implementing effective retention strategies.
- Ensuring Seamless Communication: Facilitates clear and effective communication between clients and legal teams, ensuring that all client needs and regulatory requirements are properly understood and addressed.
- Maintaining Consistency: Implementing strategies to ensure continuity of client interactions and sales processes.
- Outreach and engagement: Actively participates in events and info-sessions both local and remote to maintain connectivity with professionals and stay updated with current trends and opportunities within FDA regulated spaces.
Expertise
Life Science Compliance, Regulatory Affairs and Legal
- Promotional Compliance: Develop, and implement promotional compliance programs, lead review committees, and counter competitor claims.
- M&A Due Diligence: Direct comprehensive scope development, due diligence investigations, findings presentations, contract customization, and post-closing integration.
- Clinical Research Compliance: Negotiate clinical trials, audit SMOs/sites, craft FDA audit responses, and represent PIs, sponsors, and CROs.
- Pharmacy Law Compliance: Aggressively represent pharmacies against state/federal agencies, PBMs, and during acquisitions.
- Manufacturing Compliance: Develop and maintain quality and compliance programs, proactively and reactively respond to FDA concerns.
- Technology Compliance: Address FDA, OIG, DOJ, OCR and other regulatory agency compliance considerations.
Experience
Former in-house counsel for multi-billion dollar PE and VC Funded Companies
Embedded Healthcare
- General counsel
- Chief compliance officer
- Chief information security officer.
Synchrogenix (a Certara company)
- VP of regulatory strategy & policy
Nostrum Pharmaceuticals
- Corporate counsel
Philadelphia College of Pharmacy
- Visiting professor
Drexel University School of Law
- Adjunct professor
Education
- Juris Doctor, School of Law Temple University
- Doctor of Pharmacy, Philadelphia College of Pharmacy
- MS in QA/RA, College of Pharmacy Temple University
- Admitted to practice law in PA/ NJ
Expertise
Research & Life Science Compliance, Regulatory Operations, and Legal
- Clinical Trial Compliance: Represent PIs, Sites, SMO/SOO, and AMCs across contracts, training, auditing, FDA interaction, and regulatory submissions
- Privacy Law: Address policies, programs, and agency oversight for HIPAA and GDPR
- Clinical Research Operations: Emphasis on building and scaling the most efficient and compliant HRPP and Site specific operational needs across regulatory agency considerations such as FDA, OHRP, AAHRPP, ORI, and NCI.
- Regulatory Requirements & Training: Provides customized training programs for Sponsors, CROs, Sites, AMCs, Cancer Centers, SMO/SOO to meet specific compliance needs in IRB, GCP, HIPAA, research misconduct, and data safety monitoring.
- Programmatic Oversight: Analyzes, rehabilitates and creates your research program across all therapeutic areas, but especially oncology, when complying with FDA, OIG, DOJ, OCR, NCI and other regulatory agency compliance considerations.
Experience
Former in-house research compliance administrator and tenured regulatory consultant in a privately held national compliance firm
Indiana University
- Quality & Compliance Manager
- Senior Compliance Project Manager
- NIH Program Manager
- Contract Officer
First Class Solutions
- Senior Research Compliance Consultant
- Research Business Development Leader
IU Robert Mckinney School of Law
- Health Law Externship Program Director
- Adjunct Professor
Education
- Juris Doctor, Indiana University Robert H. McKinney School of Law
- Masters, International Research Ethics: Indiana University, School of Liberal Arts
- Admitted to practice law in IN
Nidhi Kulkarni
Chief of India Operations,
Indian Counsel, US Paralegal
Expertise
Chief of Indian Operations/ Indian Attorney / US Paralegal
- International Compliance and Operations: Manages FDA expectations to review promotional materials and conduct due diligence, ensuring global operations adhere to stringent standards.
- Legal Document Drafting: Draft legal agreements as they relate to clinical trials and international law.
- Client-Centric Research: Undertaking in-depth legal and regulatory research. Provides comprehensive guidance to clients, safeguarding their interests and contributing to their success.
- Digital Marketing Leadership: Directs innovative digital marketing strategies to bolster the firm’s online presence and generate leads, using analytics to refine approaches and showcase results.
- Client Engagement and Retention: Develops and executes client engagement strategies, utilizing CRM tools to enhance communication and maintain client satisfaction.
Experience
Former in-house counsel for multi-billion dollar PE and VC Funded Companies
- Practiced Law at Multiple Law Firms
- Co-Author: RAPs Training Program on FDA Law
Kulkarni Law Firm
- Chief of India Operations
- Indian Counsel
- US Paralegal
Education
- LL.B., KC Law College, Mumbai
- BS Finance, Rutgers Business School, Rutgers University
Expertise
Head of Global Marketing and Sales
- Strategic Brand Development: Shape and grow the firm’s brand to appeal to our core sectors, launching campaigns that boost our standing and stick to ethical guidelines.
- Creative Direction: Manage the creation of marketing materials, ensuring they’re on-brand and meet FDA and healthcare ad rules.
- Client Engagement and Retention: Enhance client relationships with targeted engagement efforts and CRM tools for better communication and satisfaction tracking.
- Cross-Functional Team Leadership: Guide a diverse team of marketing and design professionals, promoting teamwork and innovation within regulatory limits.
- Market Intelligence and Adaptation: Keep pace with market and regulatory shifts in our industry, adjusting strategies to stay ahead and compliant.
Expertise
Podcast and Videocast Audio and Video Design
- Multimedia Strategy: Develop and execute a strategy using podcasts and videocasts to create compelling content.
- Content Oversight: Manage the production of engaging audio and video content, ensuring alignment with our brand and strategic goals.
- Technical Innovation: Lead the technical side of content creation, keeping up with and incorporating the latest multimedia technologies and trends.
- Engagement and Growth: Use metrics to refine strategies, increasing audience engagement and expanding our reach.
