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.