- 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.
Associate,
- Phone: +1 202 239 3241
- Email: krupa.zachariah@alston.com
Krupa helps clients tackle the complexities of regulatory and compliance issues that arise under FDA laws and regulations.