Pharmaceutical

Results You Can Trust

Pace Analytical Life Sciences has unparalleled experience with pre-product release testing of pharmaceuticals. Partnering with Pace Analytical Life Sciences for your pharmaceutical testing needs, you gain an experienced partner that will support and advance your accomplishments.

From Innovation to Market Faster with Pace Analytical Life Sciences

Pharmaceutical Testing services available through Pace Analytical Life Sciences include:

Pace Analytical Life Sciences leads the industry in quality testing for regulated industries, but retains the flexibility to customize services to meet each customer’s needs.

Contact Pace Analytical Life Sciences about your quality testing needs today.

Microbiology

Pace Analytical Life Sciences’ state-of-the-art Microbiology laboratories offer a full array of cGMP microbiology testing services in support of sterile and non-sterile products, including:

  • Environmental Monitoring
  • Raw Material Testing
  • Method Development and Validation
  • Microbial Contamination Investigation
  • Microbial Limits, USP [61]
  • Antimicrobial/Preservative Effectiveness Testing, USP [51]
  • Facility Bioburden Testing, USP, EP, JP, AOAC, BP
  • Bacterial Endotoxins, USP [85] (Gel Clot)

Our experienced professionals of degreed microbiologists provide expertise in compendial method testing, method development, method validation and custom research projects.

Pace Analytical Life Sciences distinguishes itself by offering access to new, cutting-edge technologies. Our expertise in rapid microbiology techniques, especially bacterial identification and characterization via ribotyping, is unique in the industry. Pace Analytical Life Sciences will partner with you to select the most appropriate technology, perform feasibility studies for your product and help navigate you through validation and FDA approval.

Contact Pace Analytical Life Sciences to discuss your current microbiology testing needs. You can also request a quote online.

Ribotyping: Microbial Identification

As part of the premier Rapid Microbiology service, Pace Analytical Life Sciences now offers rapid, genetic-based identification of microbial isolates using the Dupont Qualicon RiboPrinter®. Pace Analytical Life Sciences invested in the RiboPrinter rapid-bacterial identification and characterization testing technology when the FDA suggested compliance guidelines for aseptic processing and high-speed bacterial identification and characterization testing. This service allows for accurate sub-species identification and characterization of bacteria in 8 hours, in comparison to conventional methods, which can take from 5-14 days.

Physical Testing

The Pace Analytical Life Sciences Physical Testing laboratory analyzes the physical and structural properties of products and materials. Specialties include testing of pressure-sensitive adhesives as well as oxygen and moisture permeability studies, method development and compendial method testing. Our staff of experienced professionals is well versed in developing solutions for a variety of products.

Physical testing studies can be performed in a temperature- and humidity-controlled laboratory.

Contact Pace Analytical Life Sciences to discuss your current physical testing needs. You can also request a quote online.

Analytical Chemstry

The Pace Analytical Life Sciences Chemistry Laboratory offers a complete line of cGMP analytical testing services. Pace Analytical Life Sciences’ analytical services include:

  • Method Development and Validation
  • Assay
  • Impurity Determination
  • Stability Studies
  • Extractables and Leachables
  • Physical/Chemical Characterization
  • USP/BP/JP Testing
  • Raw Material Testing

The laboratory also has considerable experience analyzing low level analytes.

Each of the chemistry professionals has a minimum of five years experience in pharmaceutical and chemical analysis. The laboratory is fully equipped with state-of-the-art analytical instruments (see the Facilities and Certifications page for a full listing). All of the laboratory work is carried out under cGMP, and full QA review is available upon request.

Contact Pace Analytical Life Sciences to discuss your current analytical testing needs. You can also request a quote online.

ICH Stability Storage and Testing

Pace Analytical Life Sciences can offer long- and short-term (accelerated) stability storage services for a variety of dosage forms in your cGMP programs. Pace Analytical Life Sciences can provide you with stability protocols and analysis of samples using methodologies developed by Pace Analytical Life Sciences or your own scientific team. Stability reports can be tailored to meet your needs.

Dedicated Stability Personnel maintain Sample Receipt, Log-In, and Chain of Custody. All stability chambers are fully mapped and continuously monitored by a validated computerized (Datatron) monitoring system with external back-up power.

Contact Pace Analytical Life Sciences to discuss your current stability and storage testing needs. You can also request a quote online.

Toxicology Formulation Sample Analysis

In early development studies, a pharmaceutical company may utilize several different solution formulations. These formulations are often prepared in a dispensary at the Toxicology Facility. Depending on the amount of available API sample (usually extremely limited at this stage), the formulations are usually prepared once a week. The dosing may be daily, and the initial dose may be used for one week.

The stability of the API in these formulations is unknown. Therefore, regulatory agencies are increasingly interested in seeing data that shows stability of the dosage over the course of administration. In addition, it is important to have data reflecting dosage at the correct concentration.

Pace Analytical Life Sciences offers Toxicology Formulation Sample Analysis to companies that may not have the resources to conduct such studies and has considerable experience in the analysis of low level analytes using LC/MS/MS and GC/MS.

Additional Expertise

Pace Analytical Life Sciences also offers precisely designed and implemented protocols, protocol development, and customized method development and validation.

Contact Pace Analytical Life Sciences to discuss your customized testing needs. You can also request a quote online.

Scope of Services for Pharmaceutical Customers

Please visit the Scope of Services page for a full listing of available tests.