The future planning of the company focuses on serving more biotech customers in the U.S., especially in the west coast area. The founder is very proud of his team’s accomplishments that include four of their clients getting their new drugs approved in 2018. Using their phase-appropriate and risk-based CMC strategies, they were able to get the client ready for IND filing within a year. He recalls a recent instance where a startup company reached out to them for CMC help to initiate clinical trials for an investigational drug from Japan. The founder has several case studies to exemplify the efficiency of their services. While about 65 percent of Syner-G’s clientele consists of startups, 20 percent of them are mid-sized and the rest are large pharmaceutical companies. “The phase-appropriate and science and risk-based CMC strategies we design for our clients make the drug development activities cost and time-efficient without compromising on compliance,” says the founder. Diligent planning and execution combined with timely interactions with the FDA are critical factors for success. Syner-G is supporting several clients who are developing life-saving drugs for unmet medical needs through “breakthrough” pathway, where compressed development timelines make the CMC activities to be on the critical path for NDA filing and commercial readiness. The phase-appropriate and science- and risk-based CMC strategies we design for our clients make the drug development activities cost and time-efficient without compromising on compliance Clients find it very beneficial to have all CMC related services offered by Syner-G under a single umbrella. They also provide project management services to ensure all these activities of the clients are managed and executed on time without any hiccups. Syner-G offers a suite of CMC services in three core areas-technical development, regulatory affairs, and quality/cGMP compliance, termed together as CMC-360. While pharma industry handled the R&D, manufacturing and analytical testing capability needs by embracing the outsourcing approach, Syner-G experts fulfill the need for qualified and experienced subject-matter-experts (SMEs) who guide and manage the outsourced work for their clients. Often, CMC road bumps that lead to regulatory issues are due to scientific and/or compliance matters like specifications, analytical methods, impurities, stability, etc. Fast forward to now, Syner-G with their full spectrum CMC-360 consulting services, has emerged as a game-changer by offering fit-for-purpose CMC activities resulting in high-quality regulatory submissions.Īccording to the founder, the ever-changing pharmaceutical industry has witnessed many small to mid-sized biotech/pharma companies having to navigate various challenges during drug development. Syner-G Pharma Consulting was born in the suburbs of Boston with a vision of becoming the global leader in science and risk-based CMC consulting firm. Prabu Nambiar, a seasoned pharmaceutical development professional, assembled a team of elite CMC professionals and founded an organization to serve the industry needs due to impending changes. Prabu Nambiar, Ph.D., Founder & Principal It was the dawn of the new millennium when FDA started a new initiative known as cGMP for the 21st Century, which encouraged pharmaceutical companies to embrace science and risk-based methodologies to innovate drug development and manufacturing processes.
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