D-Anchor QR&C LLC work to ensure our clients maintain compliance with regulatory requirements, FDA guidance, and other ISO standards. Startup to well-established fortune 500 companies will benefit from our services rooted from the notion that Quality is built-in by Design. Our staff of compliance specialists is equipped to meet any regulatory challenges. Our Regulatory Compliance services include:
- Pharmaceutical Drugs and Medical Device Law Consultation
- FDA Registration and Renewal
- Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.
- Establishments or facilities that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register with the FDA.
- Establishment registration is to be renewed annually thereafter per the FDA imposed timeline.
- FDA Product Listing
- Domestic and foreign drug manufacturers, repackers, or re-labelers are also required to list all of their commercially marketed drug products with the FDA.
- Although not regulated or required by the FDA, Cosmetic products can Voluntarily be registered with the FDA under the Cosmetic Registration Program (VCRP). The VCRP is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.
- FDA Labeling, and Ingredient Review
- Cosmetics, OTC Drugs and Medical Devices marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the authority of these two laws.
- To prevent labeling mistakes and costly remediation, D-Anchor QR&C can review your labels and Ingredient lists for compliance with FDA regulations adequate instructions for the proper use and dosage, Warnings statements, Listing of Active Ingredients, and any other misleading claims.
- Mock FDA Inspection and ISO 22716 Certification
- The U.S. Food and Drug Administration is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 “Factory Inspection”. D-Anchor QR&C can help your organization prepare for such inspection and prevent potential violations of the FDA requirements through effective internal quality audits which ensure that your Standard Operating Procedures (SOPs) are completely aligned with all documentation and operations at a minimum.
- Regulatory Observation Responses & Remediation
- If your establishment has been issued a 483 or a warning letter, D-Anchor QR&C can guide you through the steps to resolve the 483 observations or warning letters, to complete the 483 response checklist, write and submit effective responses to the FDA throughout the resolution process.