About

About Pace Life Sciences About Pace Life Sciences Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of 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. At Pace, we are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. You can find out more at pacelifesciences.com. Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of 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. At Pace, we are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. You can find out more at pacelifesciences.com. Pace® Life Sciences offers a comprehensive suite of contract services—including CMC development, clinical trial material (CTM) manufacturing, regulatory consulting, and facility support—for the pharmaceutical, biopharmaceutical, and gene therapy industries. With a nationwide network of CDMO sites, GMP analytical labs, and support centers, we are positioned to move your program efficiently from early development through commercialization. Our expert teams and investment in state-of-the-art facilities reflect our commitment to providing reliable, high-quality services and a seamless client experience at every stage. Pharmaceutical Development Services Our development labs offer IND-enabling support to advance therapies through preclinical stages, including the characterization of: Small molecules Biologics (proteins, peptides, antibodies, ADCs) Gene therapies (e.g., oligonucleotides) Early-Phase Development Services: Lyophilization and spray-drying process development Analytical method development and validation Test article preparation CTM manufacturing and packaging Technology transfer to our GMP facilities ensures a smooth progression from preclinical through commercial phases, in full compliance with regulatory standards. Integrated Services to Support Your Entire Lifecycle Pharmaceutical Development Preformulation & formulation development Bioavailability enhancement Clinical supplies manufacturing: Sterile products Tablets, capsules Solutions, suspensions Semi-solids, creams, ointments Clinical packaging Analytical development and method validation Solid-state API characterization Nitrosamine risk assessment Extractables/leachables testing Stability storage & testing GMP Laboratory & Commercial Support Raw materials clearance In-process and finished product testing ICH stability programs Reference standard management Elemental impurities & physical testing Microbiological testing Facility Services Commissioning & qualification Utility & equipment validation Lab relocations Consulting Services Regulatory strategy and agency interaction Quality and compliance consulting Flexible Service Models and Commitment to Quality Capacity: We support clients of all sizes with adaptable engagement models, including fee-for-service, dedicated resources, FTE programs (on-site or at client locations), ensuring cost-effective solutions. Quality: Our facilities have a strong track record of successful inspections by regulatory agencies and clients, delivering the high-quality data needed to move your program forward. Reliability: Our integrated approach ensures your program stays on schedule—on time and on budget. Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of 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. At Pace, we are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. You can find out more at pacelifesciences.com.