- Assessed the regulatory status and compliance obligations for medical devices and drugs.
- Assisted several companies with FDA Current Good Manufacturing Practice (CGMP) regulatory issues such as FDA inspections, regulatory meetings, and warning letters.
- Provided counsel to health systems on the implications of novel litigation to FDA regulated products.
- Reviewed cosmetic companies’ product labelling for regulatory compliance, claim substantiation, and litigation risk.
- Assisted wholesale distributors with regulatory obligations related to the Drug Supply Chain Security Act.
執業律師,
Krupa helps clients tackle the complexities of regulatory and compliance issues that arise under FDA laws and regulations.