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Clinical Trial Manufacturing Services

Clinical trial materials manufacturing services and specialized technologies to support clients in early pharmaceutical development through phase IIIa clinical trials; sterile injectables, ophthalmics, otics, tablets, capsules, solutions, suspensions, semi-solid, and other dosage forms.

IMPROVING OUR HEALTH

Our investment in state-of-the-art facilities and highly trained experts emphasizes our commitment to delivering positive customer experiences across all phases of pharmaceutical and biopharmaceutical development. From early-stage research and development, to clinical trial materials production and GMP manufacturing support, we are dedicated to providing the best, and most reliable analytical testing services. Pace Analytical® Life Sciences is well-equipped to handle almost any project regardless of scope or complexity.

CMC Pharmaceutical Development

Pre-formulation characterization and formulation development services for complex pharmaceuticals and biologic therapies. GMP clinical trial materials manufacturing with specialty spray dry dispersion and lyophilization process development services.

GMP Clinical Trial Materials

Formulation development, process development and specialty services (spray drying, nano milling, hot-melt extrusion and lyophilization) to manufacture phase I/phase II clinical trial materials (CTM).

GMP Testing Laboratories

Provides the highest-quality chemistry and microbiology testing services following current good manufacturing practices (cGMP) to support complex pharmaceuticals, biologic, and drug-device combination therapies.

Literature, Accreditations & Documentation

  • FDA Registered
  • DEA Registered (Class I-IV)
  • GMP Compliant
  • ISO 17025 Accredited

Where and how we Work

Pace Analytical Life Sciences operates seven state-of-the-art facilities providing  CMC Pharmaceutical development and manufacturing (CDMO) services FDA-registered, cGMP-compliant contract research organization (CRO) services. Each of our facilities have long-established histories of very successful product development and commercialization with excellent audit outcomes from both regulatory agency and partner-client reviews.

  • CDMO Clinical Manufacturing

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