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. 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. 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. 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.
According 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. Often, CMC road bumps that lead to regulatory issues are due to scientific and/or compliance matters like specifications, analytical methods, impurities, stability, etc. 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.
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. They also provide project management services to ensure all these activities of the clients are managed and executed on time without any hiccups. Clients find it very beneficial to have all CMC related services offered by Syner-G under a single umbrella.
Syner-G leverages its CMC technical and regulatory expertise in combination with global supply chain relationships to ensure the client’s drug substance and drug product requirements are fulfilled efficiently both from time and cost perspectives. “We play a critical role as a seamless extension to the development team of clients and helping them identify and manage contract development, manufacturing and testing sites for drug substance and drug products,” says the founder of Syner-G Pharma Consulting.
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
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. Diligent planning and execution combined with timely interactions with the FDA are critical factors for success. “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.
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 founder has several case studies to exemplify the efficiency of their services. 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. Using their phase-appropriate and risk-based CMC strategies, they were able to get the client ready for IND filing within a year. The founder is very proud of his team’s accomplishments that include four of their clients getting their new drugs approved in 2018.
The future planning of the company focuses on serving more biotech customers in the U.S., especially in the west coast area. Regarding geographical expansions, Syner-G Pharma Consulting is keen to partner with international clients from countries like Japan where they are unclear and/or hesitant to adopt risk-based approaches in drug development. Syner-G believes this can help bring many potential lifesaving medicines to clinical trials and eventually to market expeditiously.