- Expands Drug Development and FDA Regulatory Expertise
Novotech, the leading Asia Pacific-centered biotech CRO today announced the acquisition of CBR International, a global product development, clinical oversight and strategic regulatory operations group.
CBR was founded in 2002 as a consultancy company focused on assisting biotechnology and pharma companies navigate FDA requirements from early-stage development through to approval. CBR adds a group of experts to Novotech to provide US and global regulatory, scientific, quality, and clinical development services. CBR’s specific regulatory expertise and services include long-range Regulatory Strategy and Writing, FDA Representation, eSubmissions, and Scientific Affairs to support requirements for cGMP commercial product development.
The acquisition will further strengthen Novotech’s capabilities in regulatory strategy and US FDA interactions and submissions including IND, IDE, NDA, BLA, Fast-Track, Break-through, and Orphan Drug Applications.
Novotech CEO Dr. John Moller said: “CBR will provide decades of FDA regulatory experience for our biotech clients. They have experience across all product types and are highly regarded for their IND expertise having managed approximately 80 INDs through all phases of development. This acquisition, together with Novotech’s existing regulatory affairs capability, creates a large global group of experts in toxicology, drug development, and global regulatory submissions support. This regulatory expertise benefits our US, European, and Asia Pacific biotech clients as they progress through the US clinical environment and navigate often complex FDA requirements.”
CEO and Founder of CBR, Dr. Jeanne Novak said: “We are extremely pleased to be joining a company the size and calibre of Novotech which brings global demand for our regulatory expertise. The US is an important region for global biotech and pharma companies as part of their clinical program development. We have the experience and track-record of directly supporting US approvals for over 10 programs. Navigating novel product development and achieving multiple approvals has built our expertise to support the complex development needs of clients worldwide which will now support Novotech clients. We look forward to working with Novotech clients to support their drug development programs in the US and globally. We are excited to continue working with our clients and bringing Novotech expanded services to our colleagues.”
Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology combines to deliver a specialist full-service biotech CRO solution.
Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world’s leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.
Novotech is the leading Asia-Pacific centered biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific the US, and Europe. For more information visit https://novotech-cro.com/contact
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