To reduce time to market, the industry is putting out new products at a faster rate and outsourcing more activities than ever before. Time is of the essence. Therefore, technology transfer during product development, whether within and between companies, needs to work perfectly the first time, exceed expectations, and meet regulatory compliance. A quality technology transfer is just as important now (if not more so).
A critical component of success is demonstrating regulatory compliance. Accidents in chemical plants due to chemical labeling problems, lack of understanding of chemicals, or both, are more common than you might believe. Chemical, physical, and hazardous properties of a product must be well documented via proper labeling, documentation, packaging, provision of safe practices, and emergency response procedures.
For the granting organization to transfer production to a receiving organization with only a secrecy agreement or sales agreement and the manufacturing procedure is not acceptable. Technology transfer plans involve much more than that to ensure that the receiving organization can carry out a chemical process safely, on time, and within budget.
ioMosaic professionals have decades of experience mitigating hazards for the chemical and pharmaceutical industries, which means you will have unrivaled efficiency and expertise to improve validation, increase efficiency, and lower costs. ioMosaic transfers data, analytical methods, and manufacturing processes. Our experts are well known for developing safety and risk management systems, guidelines and standards, and audit protocols around the globe. We can help you understand the requirements and comply with global industry standards such as Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Occupational Health and Safety Act (OHSA), OSHA’s PSM Standard, CCPS, ACC, API and other RAGAGEPs, and the EPA’s Risk Management Program (RMP) Rule.
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