- 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.
- Assisted a client on site at a drug manufacturing facility with their response to an FDA Form-483.
- Provided counsel to health systems on the implications of novel litigation to FDA regulated products.
- Reviewed cosmetic companies’ product labeling 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.