At Syner-G BioPharma Group, Chemistry, Manufacturing, and Controls (CMC) is our sole focus. We provide in-depth expertise across the three key elements of CMC: Regulatory Services, Technical Development and Quality/GxP Compliance. We call this CMC 360™. It’s our focus, our passion, and our lifeblood.
We fully recognize that 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.
With patient safety and regulatory compliance always top of mind, Syner-G helps to design and implement science- and risk-based, phase-appropriate CMC solutions to expeditiously advance your drug during development and/or sustain the commercial supply chain post-approval.
Our CMC 360 business units operate in an integrated fashion to ensure that that the solutions we provide fully conform to the scientific standards and regulatory requirements.
The CMC regulatory landscape is continuously evolving and presents a steady challenge to the development of new small molecules, biologics, cell and gene therapies, and medical devices. At Syner-G, we understand this landscape. We are experienced and passionate in helping our clients to design, plan, and execute CMC strategies critical for the successful development of new drugs.
Syner-G specializes in offering CMC development solutions for virtual drug development. Our subject matter expertise spans drug substance, drug product, and analytical method development. Across our entire organization, we proactively employ Quality by Design (QbD) principles to support all phases of drug development and commercial manufacturing.
Regulatory compliance, including adherence to cGxP requirements, is necessary to ensure safety and efficacy of pharmaceutical supplies. It is also a key component for successful product development, regulatory approval, and maintaining an uninterrupted supply chain. Syner-G offers guidance to design and implement the proper approach to ensure quality compliance.
Cell and gene therapy innovator companies face new and unique challenges as they plan, build-out, and scale-up their manufacturing facilities to deliver life-saving new therapies. These challenges include deploying the right IT solutions in the right sequence to enable complex manufacturing capabilities.
The CMC Landscape
Regulatory and quality compliance are statutory requirements under the US Food, Drug, & Cosmetic Act and other federal regulations, and similar regulations apply outside the US with other global health authorities. Compliance requirements apply to both investigational and marketed products.