BRIGHTWAY HOLDINGS SDN. BHD.

FDAbasics is a full-service FDA compliance and regulatory consulting firm with 30+ years of experience serving food, drug, medical device, and cosmetic manufacturers worldwide. The company specializes in US Agent appointment and representation for foreign companies, FDA facility registration and renewal, product listing and labeling compliance reviews, NDC/GUDID submissions, 510(k) support, DMF filings, ANDA/IND/NDA application assistance, MoCRA compliance, FSVP compliance for food importers, and GDUFA self-identification for generic drug manufacturers. FDAbasics maintains a US-based team in Brooklyn, NY, offering transparent pricing, rapid registration turnaround (2 business days), and comprehensive regulatory support across all four FDA-regulated industries. The firm is 5-star rated on Trustpilot and Google, serving clients in 100+ countries.