Welcome to R. FLORA & ASSOCIATES
R. FLORA & ASSOCIATES has a proud history of serving the FDA regulated industries since 1989. Our qualified consultants and associates are dedicated to meeting the needs of our customers.
Find out more about the services we provide by clinking on the tabs related to you products and needs.
R. FLORA & ASSOCIATES, INC.
About R. FLORA & ASSOCIATES
R. FLORA & ASSOCIATES is a regulatory consulting firm offering its services to the food, drug, cosmetic, and dietary supplement industries. We have an extensive reference library, subscribe to several government and trade publications and services, and have numerous regulatory contacts.
Besides our in-house staff, we have close associations with experts and consultants in many related fields. While specializing in quality control, quality assurance, and regulatory affairs, we also offer expertise in product development and technical research.
R. FLORA & ASSOCIATES specializes in:
- Food, drug, cosmetic, and dietary supplement label and labeling preparation and review, ingredient review, import and export issues, establishment registration, drug listing and GMP issues.
- Functioning as U.S. Agent.
Either in conjunction with or In addition to the services listed above, we can:
- Answer questions and solve problems over the telephone.
- Make blind inquiries on your behalf with the various regulatory agencies.
- Design batch records, lab reports, packaging reports, release stickers, and any other forms, stickers, and labels used in the manufacturing, packaging, processing, holding, and control of foods, drugs, cosmetics, and dietary supplements.
- Develop raw material and product specifications.
- Prepare Standard Operating Procedures.
- Perform company and vendor audits.
- Qualify analytical labs.
- Assist clients to qualify as drug manufacturers or as manufacturers of dietary supplements.
- Prepare, or assist with, state and federal submissions such as drug master files, INDs, NDAs, ANDAs, NDI submissions, food additive petitions, etc.
- Develop new products.
- Perform technical literature searches.
- Assist with sterilization validation and other microbiological issues.