Using state of the art instrumentation & over 25 years of professional analytical experience Residuals & Elementals can assist with drug product compliance.
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Residuals & Elementals, LLC | Consulting, Residual Solvent Analysis, & Elemental Purity Analysis | resielem.com Reviews
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Using state of the art instrumentation & over 25 years of professional analytical experience Residuals & Elementals can assist with drug product compliance.
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Company Status | Residuals & Elementals, LLC
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July 25, 2015. The site is ready for Quality Inspections, and is currently able to generate cGMP data. Using state of the art instrumentation, Residual Solvent and Elemental Impurity methods are being developed and subsequently validated for many common raw materials used in drug product manufacturing. Future updates will include a listing of available validated methods for many common drug product excipients as well as the corresponding vendor qualification. Leave a Reply Cancel reply.
Blog Archives | Residuals & Elementals, LLC
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July 26, 2015. On December 2nd, 2014, Residuals and Elementals LLC was formed to provide support to Pharmaceutical companies with a narrow focus on Residual Solvent and Elemental Impurity analyses. Many companies do not have the ICP instrumentation required to meet the FDA’s requirement for a complete Elemental Impurity summary effective January 1st, 2018. This implies that a … Continued. July 25, 2015. 2007 Eastpark Blvd. Cranbury, NJ 08512 908.838.4298.
Drug Application Consulting | Residuals & Elementals, LLC
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Drug product applications have a lot of moving parts and a delay in approval or the rejection of the application can be devastating to a company. That is why R&E offers complete application consulting services. We can help you through the process from start to finish, or provide an application review before submission. Our Consulting Solutions Include:. Technical and analytical guidance as needed. Review of drug product applications (IND, NDA or ANDA) with complete gap analysis and recommendations.
Elemental Impurity Analysis | Residuals & Elementals, LLC
http://resielem.com/elemental-impurity-analysis
Beginning 01/01/2018, the FDA will require an elemental impurity summary for new drug applications. In the interim, this data may also be required for pending applications or commercial drug products. This analysis will require the quantification of all toxic elements that may be present in your drug product in addition to cadmium, arsenic, lead, and mercury. With Residuals and Elementals LLC you get:. Development of an ICP-MS analytical method for a raw material or drug product. Interested in our work?
Residual Solvent Analysis | Residuals & Elementals, LLC
http://resielem.com/residual-solvent-analysis
There are often trace levels of chemical residues left behind in the drug substances as well as the excipients. These organic residual impurities may be used in the manufacturing process, be a by-product of the process or inherent to the material. With Residuals and Elementals LLC you get:. Development of a GC analytical method for a raw material or drug product. Validation of a GC analytical method for a raw material or drug product. Specialists in residual solvent analysis. Our narrow focus will en...
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Cedar Brook Corporate Center. 4A Cedar Brook Drive. Cranbury, NJ 08512. Cell: (908) 377.9004 Office: (609) 655.5400. East Park at 8 A. PRESENTATION OF ALL AVAILABILITIES. Layout of the Campus. Tenants at Cedar Brook Park and Eastpark. Our tenants include a mix of established companies and firms in life science, technology and R&D, including:. Fisher Capital Corp LLC. Galderma R and D, LLC. Iris Id Systems, Inc. Kronos Worldwide, Inc. 5 Cedar Brook Drive. 1 Cedar Brook Drive. 4B Cedar Brook Drive. CMIC st...
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Residuals & Elementals, LLC | Consulting, Residual Solvent Analysis, & Elemental Purity Analysis
The drug product approval process can be daunting, but Residuals and Elementals LLC has the experience and expertise to provide an unbiased third party application review with a documented detailed gap analysis. Residuals and Elementals LLC provides residual solvent analysis using Agilent’s latest GC [7890B] with either direct or headspace sampling. R&E also has a GC-MS for unknown identification as needed. 2007 Eastpark Blvd. Cranbury, NJ 08512 908.838.4298.
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