Christy Ngo

I’m a Regulatory Affairs Specialist and Designated Representative in Charge with experience reviewing and approving product labeling for accuracy and adherence to guidelines. I prepare and file cosmetic, OTC, and prescription drug submissions for FDA approval via FDA Direct to support faster market entry for products.

I maintain detailed regulatory records and assemble core records and supporting documentation for regulatory file applications. I also create product technical file packages for global compliance certifications and international registration, helping ensure standards are met while reducing development costs.

In addition to submission work, I participate in audits with inspecting regulatory bodies, implement corrective actions for regulatory compliance, and provide pre-, ongoing, and post-inspection follow-up assistance. I help develop, review, and approve Standard Operating Procedures to strengthen compliance across teams.

As a Designated Representative in Charge for a virtual wholesale drug distributor facility, I handle compliant prescription drug operations including personnel training, security, housekeeping/sanitation, recordkeeping, storage, and handling. I process and report post-marketing and clinical trial Adverse Events (AEs) to the FDA and maintain 100+ pharmaceutical wholesale drug distributor licenses and facility business licenses.