RCI Newsletter - Issue VII
Custom Synthesis for Medical Device Markets
Over the last decade, the medical device market more than ever has relied on new chemistries, particularly with respect to new drug-device combinations. Emerging companies needing to differentiate their novel technologies increasingly depend on specialized chemistry. Advances in medical devices with chemical components require the expertise of highly-skilled synthetic and analytical chemists in organic, polymer or inorganic chemistry. Potential outsourcing partners must possess a complex understanding of cGMP quality standards and other compliance regulations related to pre-clinical, first-in-man studies or full validation testing.
Frequently, medical device companies lack sufficient chemistry-focused human capital, despite the aforementioned trend in product development. Fortunately they can enlist Richman Chemical as their primary CRO/CMO partner to evaluate the technology, optimize scale-up and ensure compliant full-scale manufacturing. This high level of expertise in the polymer and inorganic areas serves the medical device space quite well, complementing our traditional strength in the field of multi-step, synthetic organic chemistry.
Richman Chemical meets the outsourcing challenges of medical device clients in numerous ways, including research and development, validated pilot manufacturing, clinical batch manufacturing, and cGMP-compliant commercial production. Please contact us to see how we can accelerate your commercialization timeline!
Featured Products and Services
Featured Service: Radiosynthesis (14C, (3H)
Richman Chemical offers one of the most consistently successful teams of radiochemists in the world, working within state of the art facilities. We perform custom radiosynthesis in support of standard research and development, as well as cGMP radiosynthesis in support of clinical trials compliant with FDA GMP guidance ICH Q7A.
Featured Unit Operation: Extraction
Richman Chemical handles toll extractions of all kinds and all scales. Some of our capabilities include:
Single or Multi-solvent Systems
Aqueous
Supercritical Fluid (SFE)
Liquid/Liquid
Use of pure ethanol
Richman Chemical serves the needs of many different markets, including food, flavor, nutritional, and industrial.
We offer multiple methods of filtration and can handle large amounts of solids in most cases. Contact us today to review your specific needs.
Featured Product: Epichlorohydrin
Epichlorohydrin is a chemical intermediate with a variety of uses, particularly in the manufacturing of epoxy resins.
Epichlorohydrin is packaged in 55 gallon drums and is available for prompt shipment from multiple storage locations.