We are the world’s leading CMC and Regulatory Affairs
solutions provider for biopharma.
We provide in-depth expertise across the three key elements of Chemistry, Manufacturing, and Controls (CMC): Regulatory Services, Technical Development and Quality/GxP Compliance. We call this CMC 360™. It’s our focus, our passion, and our lifeblood.
Global Regulatory Affairs
With our acquisition of Impact Pharmaceutical Services in early 2022, we provide the complete suite of regulatory affairs services including regulatory strategy, publishing, and tactical activities, including global regulatory submissions, as well as regulatory CMC. Our team is passionate about providing expert guidance that spans the regulatory landscape.
Our highly experienced team of medical writers is committed to providing you with clear and concise documents that are sound from both a scientific and regulatory perspective. They have significant experience authoring a variety of regulatory documents across a wide range of therapeutic areas and all phases of development.
Our level of dedication to CMC is rare. The entire Syner-G organization is built around the premise of guiding small molecule, biologics, cell and gene therapy, and medical device innovators through the CMC process. We strongly believe that no other firm knows CMC better than we do.
Our team excels at presenting information to regulators in a clear and simple way based on the data. We are focused on getting them the information they need, without spending unnecessary time and resources on what they don’t need.
What makes us special is the way we work. From our client’s perspective, it’s like flipping a switch. Just bring us on board and watch us make CMC happen. We know what needs to be done, how to do it, and how to communicate it to the regulators.
Syner-G By the Numbers
Proven Legacy of Successfully Working with Small, Medium, and Large BioPharma Clients.
Years Average Industry Experience of Sr. Consultants
INDs and IND Amendments Filed
Post-Approval Major Supplements
Total Clients Served
We fully recognize that each client and each project is unique, and the CMC and regulatory requirements vary depending on several factors such as complexity of the molecule, formulation, indication, patient population, and stage of development. With patient safety and regulatory compliance as the primary objectives, Syner-G helps to design and implement science and risk-based, phase-appropriate solutions to expeditiously advance your drug during development and/or sustain the commercial supply chain post-approval. Our CMC 360 and Regulatory Affairs business units operate in an integrated fashion to ensure that the solutions we provide fully conform to the scientific standards and regulatory requirements.
The Syner-G Philosophy
We believe that there are no second chances to make a first impression, so our focus is on doing it right the first time, and every time thereafter. We demonstrate high-level technical competency in the content we submit and the justifications we present. In face-to-face meetings with regulators, we aim to establish integrity and trust by substantiating all our claims with data.
One of the things that sets us apart is the collective knowledge and intelligence of our team. We have a proven, rigorous approach to problem solving. We pride ourselves on our ability to think on the fly. Wherever possible, we look to point out issues early to avoid problems later, often seeing what others have missed.
Careers at Syner-G
Syner-G BioPharma is a fast-growing organization and we are always looking for qualified professionals with experience in Regulatory, Technical, Quality, IT Systems, and Medical Writing to join our team.
FDA News & Updates
The latest news, updates, and press announcements from the U.S. Food and Drug Administration
2 Park Central Drive, Suite 110
Southborough, MA 01772