Pharmaceutical Development
Pharmaceutical development is a multifaceted field that encompasses a range of critical activities from Chemistry, Manufacturing, and Controls (CMC) development to strategic consulting and project management. At Syner-G, we integrate these diverse aspects to provide comprehensive solutions that advance your drug substances (DS) and drug products (DP) from concept to commercialization. Our approach ensures that every project is not only compliant with the latest regulatory standards, but also optimally positioned for market success.
Our team excels in managing complex challenges associated with both DS and DP development. Collaborating closely with clients, we guide CMC decisions on key topics such as Active Pharmaceutical Ingredient (API) starting materials, critical process parameters (CPPs), and quality attributes (CQAs). As your dedicated CMC development partner, we employ advanced strategies like Quality by Design (QbD) to enhance product and process design from early to mid-stage development phases.
As a virtual CMC development organization, we excel in strategic planning and tactical oversight, ensuring that your pharmaceutical development is both efficient and compliant with regulatory standards.
Our CMC Consulting Services
CMC is mission critical. Our comprehensive CMC consulting services support biopharmaceutical companies in navigating the complexities of drug development from first-in-human studies through commercialization.
With a focus on regulatory strategy and compliance, quality management systems, manufacturing process optimization, and analytical and formulation development, we ensure your projects meet and exceed industry standards.
Our expertise includes a wide range of services tailored for early-to mid-stage biotech and pharmaceutical companies operating under a virtual drug development model.
These services encompass:
Leading-edge drug substance synthesis and chemical/process development
In-depth preformulation and formulation oversight
Rigorous development and implementation of control strategies for genotoxic impurities
Advanced analytical method development
Strategic management of contract manufacturing and quality testing resources
Developing Complex Biologics as Therapeutic Modalities
We provide end-to-end, scientifically-driven support for the development of complex biologics, including monoclonal antibodies and cell and gene therapies. Our comprehensive services cover all phases of biologic development, from upstream and downstream process optimization to clinical and regulatory strategy implementation.
Our biologics expertise encompasses:
- Process development and optimization for both upstream and downstream processes
- Scale-up, technical transfer, and process validation
- Analytical and bioanalytical method development
- Risk assessments and comparability studies to meet regulatory requirements
- Antibody-drug conjugates, vaccines, plasma protein therapeutics, fusion proteins, and bispecifics
Ensuring Success in Cell and Gene Therapies
Our expertise extends to the cutting-edge fields of cell and gene therapy, where we develop and validate processes and manage regulatory submissions for innovative treatments like CRISPR and CAR-T therapies. We ensure that each project meets stringent regulatory standards and achieves clinical milestones efficiently.
Key Areas of Expertise
CMC Development
At Syner-G, we specialize in the comprehensive development of CMC strategies that ensure your products are not only compliant with regulatory requirements but also optimized for commercial success.
CMC Consulting
Our consulting services provide in-depth guidance on navigating the CMC regulatory landscape, helping you to implement effective and innovative strategies.
CMC Project Management
We offer expert project management services to oversee and coordinate all aspects of CMC development, ensuring that your projects proceed smoothly and efficiently from concept through to completion.
Discovery Sciences
Syner-G’s Discovery Sciences team provides comprehensive medicinal chemistry services to support the journey from early discovery to clinical candidate nomination. We help design and optimize compounds to meet key therapeutic goals.
At Syner-G BioPharma Group
