People Advancing Science
Pace® Life Sciences, LLC, a full-service contract development and manufacturing organization (CDMO) and subsidiary of Pace® Science and Technology Company, announced today that it has acquired Meridian BioGroup (Meridian). Meridian specializes in bringing industry experts from regulatory affairs, quality, validation, and related backgrounds to meet its clients' needs in FDA-regulated environments.
"Our clients value our technical expertise and commitment to supporting them in rapidly advancing their programs through the clinic and onto commercialization," said Eric Roman, CEO of Pace®. "The acquisition of Meridian BioGroup adds an array of strategic services to our portfolio to further help clients with regulatory guidance and strategy, and to help them develop and maintain biopharmaceutical operations and quality management systems that meet regulatory requirements."
Expertise gained through the Meridian acquisition allows Pace® to extend the following capabilities to its clients:
- Regulatory guidance and strategy supporting applications and submissions.
- Quality system development and assessment of existing quality systems.
- Remediation of audit or inspection findings.
- Validation master planning.
- Validation of facility, utility systems, and process equipment.
- Computer system validation.
- Third-party onsite and offsite auditing capabilities.
"The addition of the Meridian BioGroup team brings new dimensions to the range of services we provide to our clients," notes Greg Kupp, President of Pace® Life Sciences. "From early regulatory strategy discussions to master planning and validation as programs scale for commercialization, we will be able to help clients at every stage of their journey on through to continued compliance, training, and auditing."
In the coming months, Meridian will transition to the Pace® brand. The Meridian operation is in Frederick, Maryland, 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. Greg Kupp oversees the management and operations of all Pace® Life Sciences locations.
Pace® is a portfolio company of Los Angeles-based Aurora Capital Partners and Leonard Green & Partners.
ABOUT MERIDIAN BIOGROUP
Meridian BioGroup LLC, is a Maryland-based validation, regulatory, and compliance contract service provider to the biotechnology and pharmaceutical communities. Meridian brings qualified specialists from manufacturing, quality control, quality assurance, regulatory affairs, engineering, validation, and related backgrounds to meet its clients' needs in FDA-regulated environments. Meridian tailors its service offerings to meet the individual needs of its clients, from large established biotechnology companies with commercial manufacturing capabilities to small start-up companies ready to move into clinical trials. MERIDIANBIOGROUP.com
ABOUT PACE® LIFE SCIENCES
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. A subsidiary of 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 United States. Learn more at PACELABS.com
ABOUT PACE® SCIENCE AND TECHNOLOGY COMPANY
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 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
Media Contact: Pam Bednar | [email protected]
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Original Source: Pace® Life Sciences Acquires Meridian BioGroup, Expanding Regulatory, Compliance, and Validation Capabilities to the Biotechnology and Pharmaceutical Markets