cGMP Manufacturing
Your cGMP Partner
We are committed to offering high-quality cGMP (Current Good Manufacturing Practice) operations. Our experienced team is adept at managing all stages of the production process, from sourcing raw materials to final delivery, in strict compliance with cGMP guidelines. We maintain an environment that minimizes the risk of cross-contamination and ensures consistent product quality for pharmaceutical, biological, tissue, and medical devices.
Experience Safe and Effective Products with cGMP Manufacturing
cGMP guidelines empower pharmaceutical companies to maintain control over their manufacturing processes and manufacturing facilities. cGMP manufacturing systems and regulations guarantee that every step, from proper design to production process, is conducted with utmost precision. Companies can confidently deliver the safest and most effective products and treatments by adhering to cGMP guidelines.
Why Choose Novex?
Small enough to listen, big enough to deliver
Experience high-quality results with our cutting-edge cGMP guidelines. We deploy the latest, most advanced technologies, ensuring fast and efficient project completion, delivering exceptional quality every time.
Industry Expertise
Gain access to a vast wealth of industry expertise in process development manufacturing processes, regulatory process, quality assurance, distribution, clinical systems, and international systems by partnering with Novex.
Quality Management
We prioritize strong quality management systems throughout every stage of the process for a seamless transition from clinical studies to commercialization. If you have an idea – we’re ready to start working on it.
Established Procedures
Take advantage of our established lab and cleanroom processes and procedures, specifically designed for current good manufacturing practices, allowing your company to work on your ideas without unnecessary delays. Say goodbye to long wait times and hello to efficient solutions.
We're an extension of your organization
We offer a comprehensive package of current good manufacturing practice operations to support you in the early stages of your program, including Chemistry, Manufacturing, and Controls (CMC), but our commitment doesn't end there. We are dedicated to assisting you as your program progresses, and will develop the necessary infrastructure to ensure ongoing support for your product's commercialization following FDA approval.
Our team of experienced professionals is ready and eager to help you solve problems and find more efficient solutions. With Novex, you can focus on creating your innovative product, treatment, or device, while we take care of the rest.
Customize your Current Good Manufacturing Practices
We understand that one approach isn't suitable for every organization. That's why we offer the flexibility for you to choose only the components that are right for your company. You can decline anything you already have in place or handle internally. Our approach allows us to support as little or as much of your program as you need to meet your minimum requirements and regulatory requirements for cGMP compliance.
Our Manufacturing Process
01.
Discover
Every successful healthcare technology has to begin somewhere. At Novex, it begins with you.
Start your journey with a seasoned professional who understands the ins and outs of product development and efficient/effective manufacturing.
02.
Develop
The idea is only the beginning. Ideas must also be evaluated and developed.
Together, we will transform your vision into a tangible reality. Our experts will assemble a skilled team and allocate the necessary resources to bring your idea to life and ensure quality assurance.
03.
Deliver
The Novex team has decades of experience bringing innovations into the marketplace.
We make sure our production is efficient and effective, allowing us to bring your life-changing products to patients faster. We also prioritize communication and transparency so everyone is up-to-date on the progress toward meeting cGMP guidelines.
Can Novex help smaller organizations?
Are you a smaller organization lacking the resources and expertise to develop and manufacture products? Perhaps your company is limited in space and unable to create a controlled environment like a clean room or lab. Maybe your current space is insufficient to meet your development and manufacturing process needs.
Whether you’re looking for assistance with thorough planning before committing financially to a product or need assistance scaling past your current limits, Novex has you covered. With our extensive space and equipment, we are ready to get started on your project or idea.
Our Capabilities
Our industry experts recognize the importance of a well-designed program. We will work with you to identify your needs and establish quality systems that work for you.
- Equipment and Process Optimization
- Sterile Fill
- Aseptic Manufacturing
- Component Manufacturing processes
- Formulation
- Agency Filing Support
Looking for expert solutions in cGMP Manufacturing?
Are you looking for a reliable and experienced partner who can help you overcome your manufacturing challenges? Look no further! We specialize in current good manufacturing practices and can ensure that your product is produced to be cGMP compliant. Let’s work together to bring your product to market. Contact us today to discuss your next challenge.
