Mergers & Acquisitions,
Legal Excellence
M&A agreements must comply with DOJ, OIG, FDA, and other legal and regulatory expectations, in addition to satisfying contractual requirements. Attorneys should ensure these standards are met.
Mergers & Acquisitions
M&A Alignment Due Diligence Services
Agreement Updates
Post Transaction Integration
M&A Alignment Due Diligence Services
Comprehensive compliance assessment for FDA-regulated companies
FDA-regulated companies must prove their compliance systems are strong and consistent during mergers or acquisitions as required by the DOJ, OIG, FDA, FTC and others.
We use the following 4 step process:
- Scope gap analyses
- Perform gap analyses.
- Produce gap analyses report
- Address identified gaps
Documentation
- Gap analyses
Services
- Audit Services
- Policy Development
- Training
Agreement Updates
Ensuring M&A agreements comply with regulatory requirements
M&A Agreements must comply with requirements from the DOJ, FDA, FTC, and OIG. We help FDA-regulated companies fix gaps, reduce risks, and protect post-sale operations.
Documentation
- Agreement Compliance Reviews
- Contract Revision Summaries
- Compliance Recommendations Reports
Services
- Agreement Drafting and Updates
- Regulatory Compliance Integration
- Risk Mitigation Strategy Development
Post Transaction Integration
Aligning operations with regulatory standards after M&A completion
Regulatory agencies like the DOJ, OIG, and FDA require post-transaction compliance. We help FDA-regulated companies align new acquisitions with regulations, reducing risks and ensuring smooth operations.
Documentation
- Operational Compliance Assessments
- Integration Gap Analyses
- Post-Transaction Compliance Plans
Services
- Operational Alignment with Regulatory Standards
- Integration Compliance Strategy Development
- Risk Mitigation and Monitoring Support
Why Legal Representation Matters
Engaging an attorney ensures compliance within the evolving regulatory landscape,
safeguards interests, and supports innovation. Attorneys bring the following advantages
Attorney-Client Privilege
Protects discussions and information beyond standard confidentiality agreements.
Comprehensive Advice
Covers not only FDA guidelines but also legal updates and DOJ/OIG compliance considerations, including privacy laws.
Compliance Support
An attorney ensures compliance, protects your interests, and supports innovation.
Why Choose the
Kulkarni Law Firm?
Contact the Kulkarni Law Firm for practical and legal guidance.
Experience
20+ years as an attorney, pharmacist, and compliance expert.
Expertise
Author, podcaster, and educator on clinical research.
Education
Teaches at Drexel, Temple, and other universities.
