RJR Consulting, Inc. specializes in providing regulatory consulting services within the life sciences industry. We have affiliates positioned in strategic locations around the globe to help provide consulting services to companies of all sizes. Our focus on client service and timely delivery has helped us build a worldwide reputation for effective, efficient consulting.
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PharmaceuticalsWhether your drug has the need for a pre-market approval, new drug application, investigational new drug or GCP/GMP compliance verification, we can provide the expertise necessary to get your product approved and out to the marketplace as quickly as possible.
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Medical DevicesNeed help determining the class of your medical device? We also provide assistance with pre-market approval, investigational device exemptions, marketing authorization, GCP/GMP compliance and CE marking for medical devices, active implantable devices and IVD’s.
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BiologicsFor products derived from human tissue or blood products, we will help you navigate the complex regulatory environment while handling any necessary clinical trial notifications, GLP/GCP/GMP compliance issues and regulatory filings.
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Combination ProductsSome products require special assistance due to being a combination of a drug, medical device or biologic. We can help you identify whether your product qualifies as a combination product and then work with the appropriate authorities to obtain the required regulatory approvals.
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Food & Dietary SupplementsTrying to get a new food or supplement to market? We can review ingredient lists, file new dietary ingredient notifications and provide a thorough review of your labeling, packaging and marketing materials to verify your claims and compliance with the appropriate regulations.
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Cosmetics & Consumer ProductsWith formulations for cosmetics becoming more complex, RJR can perform ingredient reviews, verify facility compliance and audit assistance, review the labeling/marketing materials and submit the notifications required by cosmetic regulators around the globe.
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Chemicals & PlasticsDo you need to check your product for banned substances or create a compliant Material Safety Data Sheet? We can provide these services for chemicals, polymers and plastics along with completing the necessary government registrations required for these substances and materials.