This collaboration combines Conscio Group’s comprehensive services in formulation development, analytical testing, and clinical trials with Kiel Laboratories’ deep expertise in U.S. market dynamics and regulatory strategies, particularly in 505(b)(2) and ANDA development programs.
Expanding Global Reach
The partnership aims to provide European pharmaceutical companies with a streamlined pathway to the U.S. market through 505(b)(2) approvals, while offering U.S. companies enhanced access to European markets. Stephan Holl, CEO of Conscio Group, stated:
“This collaboration allows us to leverage Kiel Laboratories’ extensive U.S. regulatory expertise, providing our European clients with a robust platform for expansion into the American market. Simultaneously US based customers will gain access to our wide-ranging service portfolio and well-established operations–a proven path into the European market.”
Comprehensive Drug Development Services
Clients of both companies will benefit from an integrated suite of services spanning the entire drug development lifecycle:
- Formulation Development: Utilizing Conscio Group’s expertise in multiple dosage forms and advanced pharmaceutical technologies.
- Analytical Testing: Leveraging Conscio’s GMP-certified facilities for method development and analytical testing.
- IMP Manufacturing: GMP accredited manufacturing of Investigational Medicinal Products (IMPs)
- Clinical Trials and Bioanalytical Testing: Accessing Kiel Labs deep regulatory expertise and Conscio’s in-house clinical units with over 600 completed BA/BE/PK studies and bioanalytical testing capabilities .
Regulatory Strategy: Capitalizing on Kiel Laboratories’ proven track record in 505(b)(2) NDA approvals and FDA interactions including post approval support across the lifecycle of the drug.
Accelerating Time-to-Market
The partnership is expected to significantly reduce development timelines and costs for pharmaceutical companies seeking to expand their global footprint. Dr. Jeffrey Kiel, CEO of Kiel Laboratories, commented:
“By combining Conscio’s European infrastructure with our U.S. market expertise, we can offer clients a truly comprehensive solution for transatlantic drug development and commercialization.”
About Conscio Group
Conscio Group is a European network of contract R&D, lab testing, and manufacturing firms offering services in formulation development, clinical testing, bioanalysis, quality control, and manufacturing solutions for small and large molecules.
About Kiel Laboratories, Inc.
Kiel Laboratories is a U.S.-based pharmaceutical R&D firm specializing in NDA 505(b)(2) and ANDA drug development and regulatory strategy. Kiel has successfully managed 15 NDA approvals with 9 commercial partners by capitalizing our 200 years of combined experience in the pharmaceutical industry. For more information about this partnership and its benefits, please contact:
Dr. Karin Cooke, Business Development Director North America, Conscio Group: Karin.cooke@consciogroup.com
Courtney Smith, Senior Director Business Development, Kiel Laboratories: courtney.smith@kiellaboratoriesinc.com
Dr. Lia Martinez-Montero, Business Development Director Europe, Conscio Group: lia.mmontero@consciogroup.com
Munich, Germany and Flowery Branch, GA – October 1, 2024
info@consciogroup.com
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