CMC Consulting by Syner-G BioPharma
Effective CMC (Chemistry, Manufacturing, and Controls) consulting services are an important part of navigating regulatory complexities and accelerating product development in the biopharmaceutical landscape.
At Syner-G BioPharma, our expert consultants provide CMC strategies and solutions to help guarantee your projects comply with current and phase appropriate regulatory and scientific expectations. When you partner with us, you leverage our expertise for your success.
Explore how our CMC consulting can make a difference to your project today.
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 enabling work 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.
Potential Challenges We Support
Our CMC consultants will help you navigate the many challenges your drug development process may encounter. Aside from the regulatory environment and industry challenges in the CMC landscape, we’ll also help with:
Regulatory Starting Materials (RSMs)
Genotoxic impurities
Quality by Design (QbD)
Defining CQAs and CPPs
Risk analysis and risk management
Control strategy/design space
Dissolution and bioequivalence
Continuous manufacturing
Drug-device combination products
Immunogenicity
Comparability protocols for cell-line change
Affordable Care Act and biosimilars
Demonstrating biosimilarity
Breakthrough products
Process validation and continuous process verification
Post-approval comparability protocols/change-management plans
Real-time release testing
Chemometrics and knowledge management
Drug Development Consulting
We are your experienced partner in the drug development sector, offering an exhaustive suite of consulting services that shepherd clients from concept through to market launch and beyond with unparalleled precision and scientific acumen. Our methodology integrates rigorous preclinical development strategies, focusing on comprehensive safety and efficacy evaluations, with advanced regulatory insights to adeptly navigate the intricate requirements set forth by the worlds regulatory bodies.
Our expertise in CMC drug development guarantees the highest standards of pharmaceutical product quality and consistency. By leveraging our industry experience and a strategic focus on efficiency, Syner-G not only accelerates the development timeline but also optimizes resource allocation, enhancing the potential for commercial success and setting a new benchmark in the pharmaceutical consulting domain.
Regulatory Strategy and Compliance
In the complex regulatory CMC environment of biopharmaceuticals, achieving compliance is one of the most critical steps of the approval process. Our team brings comprehensive insights and experience in developing strategic pathways that streamline the approval process.
We thoroughly understand regulatory requirements, craft strategic plans to navigate potential hurdles and offer continuous support to make sure your project remains compliant with evolving regulations.
Quality Compliance
Syner-G excels in developing and implementing quality management systems that ensure consistency, compliance, and continuous improvement. By setting phase appropriate processes and procedures, we help your products meet the rigorous quality standards demanded by the industry and regulators alike. Our approach safeguards product quality and enhances operational efficiency, reinforcing your market position.
Pharmaceutical Development
Our pharmaceutical development services harness comprehensive CMC solutions to accelerate the journey of drug substances and products from ideation to market, specializing in early to mid-stage biotech and pharma ventures. With a focus on process and product development, analytical method innovation, and seamless management of contract development and manufacturing, we pave the way for small molecules, peptides, oligonucleotides, advanced biologics, gene, and cell therapies.
Our end-to-end expertise spans the entire lifecycle or a new product from preclinical to post-commercial support so your breakthroughs achieve their full potential.
How Our CMC Consulting Expertise Benefits You
Partnering with Syner-G BioPharma for CMC consulting services means bringing a plethora of benefits to your product’s approval process.
Scientific Technical Writing
With our scientific technical writing, your project will excel in elucidating complex concepts, such as dosage form development, intricately weaving these technical narratives into the broader tapestry of CMC consulting. Our meticulous attention to detail makes sure that every aspect of your drug’s scientific story, from laboratory to market, is communicated with precision, and in a manner proven to be easily understood.
Accelerate Time to Market
One of the most significant advantages of working with us is the potential to significantly reduce the time it takes to bring your products to market. Our vast experience allows us to present unique solutions to complex problems by:
- Streamlining development and approval processes by identifying the most efficient pathways while balance risk and cost.
- Anticipate, mitigate and navigate regulatory hurdles swiftly, preventing delays.
- Facilitate quicker decision-making through expert guidance, ensuring your project stays on track and within timelines.
- By optimizing each phase of the development process, we help you achieve your milestones faster, bringing valuable biopharmaceutical products to the patients who need them sooner.
Mitigate Risks
The development of biopharmaceutical products is fraught with potential risks, from regulatory compliance issues to challenges in manufacturing. Syner-G Biopharma’s CMC consulting team plays a crucial role in identifying and mitigating these risks early and throughout the product lifecycle.
- Our early involvement helps foresee regulatory, quality, and technical risks, allowing for proactive measures.
- Continuous monitoring and adjustment of strategies in response to emerging risks and regulatory changes ensure sustained compliance and project viability.
- Expert risk assessment and management strategies are tailored to your specific project needs, minimizing potential setbacks and ensuring smoother progress.
- Mitigating risks effectively reduces the possibility of costly delays and enhances the overall success rate of your projects.
Clinical Supply Management
We adeptly integrate clinical supply management with our CMC consulting services, so clinical trial materials are efficiently managed. We work seamlessly across CMC and the clinical team to optimize the manufacturing, packaging and labeling to shipment resulting in flawless trial execution.
By marrying clinical supply logistics with CMC oversight, we streamline drug development processes, creating a timely trial progression and maintaining the highest compliance levels.
CDMO Selection
We select CDMOs that align with both CMC standards and the broader objectives of the drug development pipeline and your corporate objectives and risk tolerance. This strategic vetting process ensures chosen partners excel in quality, reliability, and scalability, which are critical for seamless project integration and execution.
By prioritizing compatibility and excellence in our CDMO partnerships, we enhance the efficiency and success of the development process.
Approval with Scientific Thought Leadership/Strategy
Our approach to scientific thought leadership and strategy is rooted in a profound commitment to innovation and excellence within the pharmaceutical landscape. We are adept at scientific research with strategic market insights to position ourselves as the top drug development consultancy.
By anticipating and navigating the complex interplay between regulatory landscapes and biomedical advances, Syner-G crafts strategies that meet the evolving demands of global healthcare challenges. This forward-thinking ethos ensures that our clients are equipped with the knowledge and methodologies necessary to pioneer new therapeutic frontiers, affirming our role in shaping the future of drug development and commercial success.
Guide Your Product to Success with Syner-G
The path to success is paved with expertise, precision, and strategic foresight — all of which you’ll receive as a client of Syner-G BioPharma’s CMC consulting. We stand ready to guide you through this journey, seeking to change challenges into opportunities and achievements.
With our specialized CMC consulting services, your project will seamlessly course through the approval process. Join our many successful clients and connect with us today.
Headquarters
100 Pennsylvania Avenue, Suite 310
Framingham, MA 01701
Contact Us
508.460.9700
info@synergbiopharma.com