Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...
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Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...
Are Your Cosmetic Company Records Ready for FDA Audits?
DarshanTalks Podcast
1 minute
2 weeks ago
Are Your Cosmetic Company Records Ready for FDA Audits?
Companies must maintain thorough records to meet FDA inspection requirements, including safety substantiation files, labeling proofs, ingredient documentation, and adverse event logs. Adverse event logs must be retained for six years (three for small businesses), while registration and product listing records require annual updates. Organized, accessible, and up-to-date records are essential not only for compliance but also for growth, due diligence, and investor confidence. Compliance is a s...
DarshanTalks Podcast
Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...
