Novex Innovations
Drug Division
Partnering with Novex Innovations: Supporting Your Drug development and manufacturing process
Novex Innovations’ Drug Division assists organizations in meeting their drug development and manufacturing requirements. We are registered with the FDA office, CDER, and are approved for European Clinical product distribution by a Qualified Person (QP). These credentials offer flexibility in supporting your clinical studies.
We specialize in manufacturing Active Pharmaceutical Ingredients (APIs) and formulating products for fill and finish applications. Coupled with our device group, we possess the expertise to work on combination products, offering comprehensive services for these unique products. Our ISO 5 Cleanrooms create optimal environments for handling sterile products.
Novex Innovations provides exceptional drug development and manufacturing services for the pharmaceutical industry, spanning from laboratory to commercial supply. Our unwavering focus is to deliver superior results consistently. Backed by our stringent cGMP standards and a proven track record of compliance, we are your trusted expert partner.
We offer a proven approach to technology transfer. With Novex, the tech transfer process is quicker, simpler, and seamless, with dedicated support provided throughout. Our approach is flexible, and our experts ensure confidence in an efficient and successful transfer at all stages of a drug’s lifecycle.
We take a proactive approach to development and validation. We use our experience to bring your ideas to commercial production efficiently.
All operations are under cGMP manufacturing, ensuring the appropriate controls required specifically for your project. With our ISO 5 cleanrooms and additional units under development, we can manufacture under the appropriate level of environmental controls suited for your program.
All manufacturing is completed with a batch record for parameter control and reproducibility.
From automation to manual operations, we support manufacturing from the smallest batch requirements to scaled-up requirements.
We provide support for all manufacturing activities from material evaluation to commercialization and every stage in between.
- FDA Registered.
- Currently registered as the sole manufacturer for multiple IND/NDA and several under development.
The Unmatched Expertise of Novex Innovations in Drug Development
Our expertise in regulations, commitment to quality in program development, and experience in product optimization give us a deep understanding of the manufacturing/development landscape and its challenges. With our agile and focused approach, we collaborate with you to swiftly or steadily develop programs at your preferred pace.
Our drug manufacturing services can help a pharmaceutical company address process gaps, meet regulatory requirements, and much more. We have successfully supported the growth of small companies, supporting them towards becoming publicly traded entities. With expertise in aseptic and sterile handling, as well as adherence to cGMP requirements, our team is dedicated to providing comprehensive assistance throughout your journey.
Comprehensive Support: Filling the gaps and beyond
We don’t believe in a one-size-fits-all approach. Think of us as an extension of your team and infrastructure, ready to fill any gaps in your drug development process while seamlessly integrating with your existing systems and partners. Our flexibility allows us to adapt to your specific needs and requirements. With over 46,000 square feet of space and an additional 100,000 square feet available for expansion, we can support you whether you’re just starting out or urgently need to scale. You can count on Novex Innovations to be there every step of the way.
Novex is an innovative company adept at assessing and swiftly implementing new technologies. Technology for pharmaceutical manufacturers from 20 years ago may be less than adequate by today’s standards so we are always assessing the latest technologies and how they can benefit you. This enables us to expedite our customers’ programs and offer them a competitive edge. As an extension of our clients, we prioritize aligning with the latest technologies and practices to deliver the essential infrastructure they need.
Our organization provides comprehensive support and infrastructure tailored to the needs of your program, ensuring its smooth progression. Unlike larger bureaucratic organizations that may deem your program too small, we are committed to its development. With a hands-on approach and unwavering support, we seamlessly integrate with your team, becoming an invaluable asset.
Ready to fill the gaps in your drug manufacturing process? Contact us to learn how we can help.
Frequently Asked Questions
Development of drugs is defined as any phase whereby drugs are introduced to the market. The initiative combines drug discovery and pharmacology, nonclinical safety testing, clinical trials, and regulatory submissions.
Ultimately, pharmaceutical research allows drug companies to bring a new drug that possesses therapeutic effects to market. In the context of the transition between preclinical and clinical research stages, this is a crucial pivotal moment as new medicines come to markets.
Pharmaceutical manufacturing is an extremely dynamic sector that faces arduous decisions. Critical thinking and imaginative thinking are essential for success.
A consumer usually cannot tell if a drug product is safe or if it will work. CGMP (Current Good Manufacturing Practice) is a regulation issued by the U.S. Food and Drug Administration, which establishes standards for the safe production of drugs to guarantee that they are consistently produced and controlled according to quality specifications. CGMP ensures drug safety, efficacy, purity, identity, strength, and quality. It is important to note that all pharmaceutical companies must comply with CGMP regulations to be approved by regulatory authorities.
Partnering with Novex Innovations gives your organization instant access to their extensive expertise, enabling you to make smarter decisions quickly.
Discover Our Other Divisions
Biologics and Tissue Division
Novex Innovations' Biological and Tissue Division provides comprehensive assistance for biologic programs, spanning from initial concept to successful product launch.
Let us fuel your innovation and turn your vision into a tangible reality!
Learn about our Biologics and Tissue Division.
Device Division
We aim to be a dependable partner in helping you with the design, development, and continuous manufacturing of your devices. Our team of professionals works closely with you to ensure the successful introduction of your products to the market.
Learn about our Device Division.
Distribution Division
We create customized inventory management and fulfillment solutions by combining manpower and automation.
Whether it's during high-demand periods or new product releases, we provide the flexibility to handle your product inventory and distribution seamlessly under your brand.
Learn about our Distribution Division.Looking for expert drug solutions?
We’re a reliable, experienced, and adaptive partner with drug manufacturing and development. If you work in the pharmaceutical industry and don’t possess the necessary infrastructure to meet your goals, then let’s start a conversation about what you need.
