CMC Regulatory Affairs

In the field of CMC (Chemistry, Manufacturing, and Controls) regulatory affairs, precision, expertise, and strategy are essential. At Syner-G BioPharma, we offer expert support in navigating the regulatory landscape, so your biopharmaceutical developments meet global compliance standards with efficiency and rigor.

Explore our expertise and start your partnership with Syner-G BioPharma.

Syner-G’s Comprehensive CMC Regulatory Services

We offer a robust suite of CMC regulatory services designed to navigate the complex landscape of drug development and approval. Our strategic and tactical services are crafted for your project’s compliance with global regulatory standards from initial investigational applications through to post-approval management.

Strategic Regulatory CMC Services

Our CMC services focus on laying a strong foundation for your project’s regulatory pathway, making sure the “right content” for all regulatory submissions and managing critical quality assurance issues that arise during development. We tailor our approach to each client’s specific needs precisely and efficiently in navigating the regulatory landscape.

Define the “Right Content” for Regulatory Submissions
We provide global regulatory guidance in preparing investigational applications (IND/IMPD/CTA/CTX), marketing applications (NDA /BLA/MAA/NDS), and Type II Drug Master Files (DMF), ensuring accuracy and compliance.

Manage Critical Quality Issues During Development 
Addressing genotoxic impurities/degradants, stability issues, material/process controls, and specifications. We also assist with formulation/process changes during CMC development.

Change Management
Providing support through investigational and post-approval stages, ensuring seamless transitions and adherence to regulatory requirements.

Regulatory Agency Meetings
Preparation and representation at critical meetings (Pre-IND, EOP-2, Pre-NDA, Type C, Scientific Advice) to discuss and align on regulatory CMC development plans and regulatory expectations.

QbD for Commercial Product/Process/Control Strategy
Implementation of Quality by Design (QbD) principles to establish a robust commercial product/process/control strategy.

Responses to Regulatory Agency Inquiries
Expert assistance in preparing and responding to queries from regulatory bodies, facilitating a smoother approval process.

CMC Regulatory Due Diligence
For in-license or out-license projects, all regulatory aspects are thoroughly evaluated and compliant.

Tactical CMC Services

Our tactical CMC services operationalize your strategic vision, focusing on the meticulous preparation of documentation and management of regulatory submissions. These services are key to maintaining momentum and regulatory conformance throughout the lifecycle of your product.

eCTD Documentation 
Expert preparation of eCTD documentation (Module 3/Module 2.3 QOS)  for investigational applications (IND/IMPD/CTA) and amendments, marketing applications (NDA/BLA/MAA/NDS), sNDA (post-approval PAS or CBE)/variations, and Type II Drug Master Files (DMF).

Annual Report Documentation 
Comprehensive support for the preparation of annual reports for INDs, NDAs, BLAs, and DMFs, continuing compliance and regulatory goodwill.

Project Management 
End-to-end management of submissions, from planning through submission to regulatory authorities.

Liaison Services with Regulatory Agencies
Acting as your representative with regulatory bodies, facilitating effective communication and negotiation.

CMC Regulatory Conformance Gap Analysis and Remediation 
Identifying and addressing gaps in CMC regulatory conformance to prevent potential compliance issues.

CMC Annual Product Review
Conduct annual reviews of CMC data for ongoing compliance and product quality.

CMC Report Writing
Preparation of detailed CMC reports covering development, stability, and validation activities.

Navigating the Dynamic CMC Regulatory Terrain

The CMC regulatory environment is perpetually shifting, introducing ongoing obstacles to the advancement of novel drugs, therapies, and medical devices. Regulatory bodies increasingly expect the adoption of innovative drug development frameworks, such as Quality by Design (QbD) and Process Analytical Technology (PAT), alongside heightened testing and control measures. These expectations pose significant CMC challenges, especially within the contemporary context of globalized research and development (R&D) and outsourced manufacturing.[RF4]

The potential for accelerated regulatory pathways brings forth additional CMC hurdles that must be overcome for the swift progress of commercial-ready processes.

Complicating these challenges is the absence of synchronized global regulations, which can muddle the path to compliance and market entry. At Syner-G, we possess deep expertise in maneuvering through this intricate regulatory maze. Our team is deeply committed to assisting our clients in devising, organizing, and implementing CMC strategies essential for the successful manufacturing process and prompt authorization of new pharmaceutical products.

      Tailored Strategy Development

      Our approach lies in the belief that each project demands a distinct regulatory strategy, sculpted to fit its unique contours.

      This conviction drives our commitment to collaborative engagements with our clients, where we look into the specifics of your project, assess the CMC regulatory landscape or the clinical trial and craft a strategy that anticipates regulatory hurdles and positions your project for success in the global market. This strategy is not static; it is a dynamic blueprint, subject to refinement and evolution as development progresses and new insights emerge.

      Comprehensive Documentation Support

      Parallel to strategy development is the meticulous task of documentation support, a service that underscores the importance of precision and clarity in all regulatory submissions. From the initial stages of drug substance development to the final submission and beyond, our medical writing services team guarantees that every document reflects the rigorous standards expected by regulatory authorities.

      This involves a detailed orchestration of the documentation process so that each submission, from investigational new drug applications to marketing authorization and post-approval modifications, is comprehensive, accurate, and fully complies with regulatory requirements.

      Utilize Our CMC Regulatory Knowledge for Your Project

      Navigating the complexities of CMC Regulatory Affairs demands a partner who understands the landscape and can guide you through it with precision and authority. Syner-G BioPharma offers that expertise, positioning your projects for success from the outset.

      Discover how Syner-G BioPharma can elevate your project — your pathway to regulatory approval begins here.

      Headquarters

      100 Pennsylvania Avenue, Suite 310
      Framingham, MA 01701

      Contact Us

      508.460.9700
      info@synergbiopharma.com

      Follow Us