Pace Analytical
3 services found

Pace Analytical services

Life Sciences - GMP Clinical Trial Materials

Oral Solid Dosage Forms for Clinical Trials

We follow current Good Manufacturing Practices (cGMP) in our clinical supplies manufacturing, packaging, and labeling services for domestic and international studies. Entrust your tablets, capsules, and powders to our experts so your clinical trials can proceed with ease. Pace® is open to supporting unique dosage form and manufacturing processes. Our manufacturing facilities meet FDA, cGMP, and EU requirements for Phase I and II clinical supplies, and are licensed with the Drug Enforcement Agency to manufacture and test controlled substances. We designed our facilities to handle a variety of manufacturing challenges such as potent compounds, light sensitive compounds, and organic solvent processing.

Formulation & Process Development

Pace® Life Sciences has decades of practical formulation development experience and expertise with sterile and non-sterile products, oral or topical dosages. Our attention to detail helps us create an appropriate formulation for your drug product that is safe, pure, and effective. Our formulation strategies will withstand FDA scrutiny and accelerate the successful commercialization and launch of your product. Sterile products include injectable solutions, suspensions, emulsions, gels, and lyophilized powders. Non-sterile products include tablets, capsules, solutions, suspensions, and semi-solids.

Sterile Fill-Finish Facility & Ophthalmics

With more than 20 years of experience in pharmaceutical research and manufacturing, we understand the specific challenges aseptic fill-finish and manufacturing presents. Our facility is carefully designed with the flow of personnel and materials in mind, which follows current Good Manufacturing Practices (cGMP) guidelines and minimizes contamination or mix-ups. Flexibility is important during early-stage clinical trials. We work with many custom configurations and develop validations for custom requirements that accommodate your needs.