Prabu Nambiar, Ph.D., Founder, & CEO, Syner-G BioPharma Group

Despite years of work and breakthroughs in technology and data mining,bringing a drug from bench to bedside remains a costly, complex, and time-consuming process.With long lead times, chemistry, manufacturing, and controls (CMC) often become the bottleneck in the path to life-saving drug launch and their commercial readiness. Adding to the complexity is the continuously evolving CMC regulatory landscape which presents a steady challengeto the development of new small molecules, biologics, cell and gene therapies, and medical devices.Thus to guide organizations to the best CMC approach for their products in line with health authority requirements and helpthem stay CMC compliant with sustainable processes, Syner-G BioPharma Group came to the forefront.

Syner-G provides a full spectrum of expert CMC consulting services toa small molecule, biologics, cell and gene therapy, and drug-device combination product innovators through a unique approach to Chemistry, Manufacturing, and Controls.“Syner-G is built to function as a seamless extension of your organization, filling your CMC needs with customized CMC solutions to expedite your drug development with maximum flexibility and efficiency without compromising quality and patient safety.” asserts Prabu Nambiar, Ph.D., the Founder, and CEO of Syner-G BioPharma Group. Syner-G’s extensive experience in strategizing risk-and science-based approaches for CMC development, using a Quality by Design paradigm, has helped multiple clients to successfully seek approval via a breakthrough development pathway.

The Illustrious Journey of Syner-G

Under the insightful leadership of Dr. Nambiar, Syner-G Pharma CMC Consulting began its journey in 2007 to meet the growing need for expert CMC consulting in the outsourced drug development paradigm. It further evolved as a boutique CMC consulting firm in 2012 when Binesh Prabhakar, the Senior Vice President, Quality Assurance and Compliance, joined the company as the cofounder. Together, they built the founder-owned-and-operated company with clear definitions of the services led by an experienced leadership team and continued growth to meet growing demand.

In 2020, Syner-G received an equity investment from Riverside PartnersLLC, a Boston-based private equity firm and subsequently, the company rebranded in 2021 asSyner-G BioPharma Group to reflect an expanded growth strategy toward becoming a broader spectrum pharmaceutical development consulting firmacross multiple areas. With the acquisition ofImpact Pharmaceutical Servicesin 2022, the firm further expanded its capabilities in the areas of regulatory and medical writing.

Pursuing Excellence with Its Value-Driven Approach

Syner-G’s strategic approach to CMC stands on its major guiding principles of patient safety and ascience-based, risk-based, and phase-appropriate approacheswith regulatory compliance. The firm consistently follows these guiding principles across three core elements of CMC—Technical, Regulatory, and Qualitywhich are termed together as CMC-360™. The firm understandsthat each client and each project is unique and the CMC requirements vary depending on several factors, including complexity, formulation, indication, patient population, and stage of development. Thus, keeping patient safety and regulatory compliance at the core, Syner-G helps its clients to design and implement science and risk-based, phase-appropriate CMC solutions to expeditiously advance the required drug during development and/or sustain the commercial supply chain post-approval.In addition to the three key verticals, Syner-G also emphasizes on the importance of Project Management in successful and timely execution as well as achievement of milestones. “Our team believes that in an outsourced model, it is not ‘outsource and forget,’ but ‘you get what you manage.’To fill this need, Syner-G has added Technical/CMC Project Management solutions as part of our service offering.So, if you are working with a CDMO, a Syner-G assigned project managerwill oversee day-to-day activities for an optimal outcome.You outsource it and we manage it,” opinesDr.Raymond Forslund,the Head of CMC Development & Project Management.

Besides this approach, what further sets Syner-Gapart from the rest is the way it works. From its client’s perspective, it’s like flipping a switch. “Just bring Syner-G on board and watch us make CMC happen. We know what needs to be accomplished, how to do it, and how to communicate it to the regulators both in the US and globally. The three functions are structured at Syner-G similar to those in a pharma company, so services can be introduced in a plug-and-play model by clients interested in any one of the areas or a combination of them,”addsDrew Barlow, MPH, SVP andHead of CMC Regulatory Affairs. Finally, the success of Syner-G also comes from its highly dedicated and experienced team of professionals with a passion for science and unwavering commitment to bringing lifesaving drugs to patients. Led by an exceptionally strong leadership team, they collectively work towards the common goal andbring great value to the organization and its clients. Syner-G has strong employee retention that is driven by a culture of teamwork and professional collaboration. The firm offers a complete opportunity to its employees to learn, grow, and advance their careers while making an impact in the development and production of life-saving and life-changing drugs.

Creating Roadmap for Better and Comprehensive Services

With the acquisition of Impact Pharmaceutical Services, Syner-G bolsters its service capabilities into medical writing, regulatory publishing, and submissions, as well as overall better support of the drug development process, it aspires to continue looking for ways to better meet the needs of the pharma and biotech industries. It plans to continue attracting and retaining the incredible talent it has while growing and adding clients via its expanding capabilities platform. “Given the continued growth of the outsourced and virtual drug development model, the demand for Syner-G’s services is continuously growing.To meet this demand, we will continue to grow the team organically, but we wouldn’t rule out future acquisitions and partnerships while maintaining our culture and continuing to live by our operating philosophies. We strongly believethe future is bright for Syner-G and look forward to the challenges and opportunities this ever-evolving industry has to offer,” affirms Dr. Nambiar.

“We are not limited by the therapeutic modality, dosage form, geography, or the size and scale of the work. Our expertise will serve us well across all these landscapes while continuing to bring folks on board to grow the organization will result in tangible and sizeable benefits for Syner-G,” concludes Mr. Frank Sorce, the Senior Director, Business Development at Syner-G.