Pace Life Sciences Acquires Biopharma Global, Expanding FDA Regulatory Affairs Strategy & Consulting Capabilities to the Biotechnology & Pharmaceutical Markets
Pace Life Sciences, LLC recently announced it has acquired Biopharma Global (Biopharma). Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs.
“Pace provides great value in our marketplace through our technical expertise and by meeting the strong commitments we make to our clients that rely on us to successfully advance their programs through development,” said Eric Roman, CEO of Pace. “The acquisition of Biopharma Global extends our reach further into regulatory strategy, guidance, and support in key therapeutic areas and greatly extends the reach of Pace® into our markets.”
Expertise gained through the Biopharma acquisition allows Pace to extend the following capabilities to its clients:
- Regulatory strategy development
- Regulatory affairs submissions including FDA and EMA applications
- IND applications
- Orphan drug consulting
- Rare pediatric disease designations
- Fast track designations
- Biologics license applications
“The Biopharma Global team brings strong expertise in early drug development with sound regulatory strategy guidance and robust submission support,” added Greg Kupp, President of Pace® Life Sciences. “These services greatly enhance the continuity of offerings we provide to our clients and helps them to efficiently drive new drug candidates through the development process.”
In the coming months, Biopharma will transition to the Pace brand. The Biopharma operation is located in Vienna, Virginia, and joins Pace Life Sciences locations near Boston, MA, Salem, NH, Philadelphia, PA, Ann Arbor, MI, San Diego, CA, St. Paul, MN, and San Germán, PR.
BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug developers advance treatments for the disease communities with high unmet medical needs. We have assembled a team of globally-recognized experts in the rare diseases and other under-served disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations and other expedited program submissions to their credit. We maintain a completely customer-centric, transparent process through the entirety of our projects. BIOPHARMAGLOBAL.com
Pace Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. Part of the Pace Science and Technology Company, Pace Life Sciences operates a network of multiple CDMO sites, FDA-registered GMP analytical testing laboratories, and regulatory and manufacturing support service centers across the US. Learn more at PACELABS.com.
Pace makes the world a safer, healthier place. For decades, Pace people have been committed to advancing the science of the pharmaceutical and biotechnology industries in our Life Sciences laboratories and supporting businesses, industries, consulting firms, government agencies, and more through our Analytical Services laboratories. Pace offers local-level service backed by a national laboratory network. For customers with in-house labs, Pace provides a range of professional services to keep their operations moving forward. Pace people work in partnership with customers by providing the service, science, and the data they need to make critical decisions that benefit us all. Learn how Pace® people are working to advance science through sustainable practices and continuous innovation. More at PACELABS.com.
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