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Biotech Research Group is a full service regulatory and product development consulting firm. BRG has an excellent reputation as a leading regulatory and scientific affairs consulting firm, which has clients and consultants in over 60 countries across the globe. The primary aim of BRG is to provide efficient and expeditious services and give the best solutions for our clients’ products that include pharmaceutical consulting, medical devices, healthcare information technology, and scientific se...
About biotechresearchgroup.com
Who we are
Welcome to Biotech Research Group (BRG), a global scientific and regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, and combination products in FDA regulatory affairs. Led by Christina Sanchez Miller, MPH, our team boasts over 20 years of experience in management, quality assurance, and research within the medical field. With a focus on ANDAs, INDs, and NDAs, we provide expert guidance to pharmaceutical companies looking to navigate the complex landscape of FDA drug submissions.
What we do
At BRG, we specialize in unlocking the potential of the 505(b)(2) pathway for generic drug makers. The 505(b)(2) is a hybrid of the 505(b)(1) and ANDA applications, offering a unique regulatory pathway that combines the benefits of both traditional routes. Our pharmaceutical consulting experts work closely with clients to leverage the advantages of the 505(b)(2) pathway, including modifications, market exclusivity, and a shorter pathway to market.
Through our comprehensive services, we assist drug developers in modifying brand name drugs to create innovative generic products that meet the needs of today’s market. From exploring new indications to developing faster-acting dosages and combining active ingredients, we help our clients maximize the potential of the 505(b)(2) pathway while ensuring compliance with FDA regulations.
Why you should use us
Choosing BRG as your pharmaceutical consulting partner means gaining access to a wealth of expertise and industry knowledge. Our team has a proven track record of success in shepherding generic drug makers through the complexities of FDA submissions and regulatory processes. By working with us, you can tap into our deep understanding of market exclusivity, the benefits of modifications under the 505(b)(2) pathway, and the strategic advantages of a shorter pathway to market.
We understand that every drug development project is unique, which is why we tailor our services to meet the specific needs and goals of each client. Whether you’re looking to bring a new generic drug to market or seeking to maximize the potential of an existing product, BRG is here to guide you every step of the way.
What can you ask?
- What are the key differences between the 505(b)(2) pathway and traditional ANDA submissions?
- How can modifications under the 505(b)(2) pathway benefit my generic drug development project?
- What is the process for obtaining market exclusivity through the 505(b)(2) pathway?
- How does the shorter pathway to market offered by the 505(b)(2) pathway impact overall drug development timelines?
- Can you provide examples of successful generic drug products developed using the 505(b)(2) pathway?
