Enabling clients in their quest to bring life-saving and life-enhancing products to patients.

CMC 360™

Our CMC 360™ vertical business units operate in an integrated fashion to ensure that the solutions we provide fully conform to all technical, regulatory and quality requirements.

Our Culture

Curious, entrepreneurial, eager to learn, and efficient, we offer a superior level of dedication to CMC that’s rarely seen.

Our Approach

Always patient safety first, science-based, risk-based and phase-appropriate.

Our Methodology

We’re highly skilled at understanding the client’s culture and becoming embedded within it.

We are the world’s leading CMC solutions provider for biopharma.

Here’s why:

01

CMC 360

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.

02

Culture

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.

03

Approach

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.

04

Methodology

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 Filed

Post-Approval Major Supplements

Agency Meetings

Total Clients Served

We fully recognize that each client and each project is unique, and the CMC 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 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 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.

Critical Thinking

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 CMC professionals with experience in Regulatory, Technical, or Quality to join our team.

FDA News & Updates

The latest news, updates, and press announcements from the U.S. Food and Drug Administration

Global Health Authorities

We regularly work with major health authorities to ensure that your life-saving products will reach the people who need them.

Headquarters

2 Park Central Drive, Suite 110
Southborough, MA 01772

Contact Us

508.460.9700
info@synergbiopharma.com

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