Analytical methods using an appropriate testing scheme are essential for the effective characterization and evaluation of drug products and the supporting components. This analytical data informs critical decisions about the safety, purity, and effectiveness of your products and materials. We offer a comprehensive selection of analytical services to support your testing needs across the drug product, medical device, and combination product lifecycle.
Pace® Life Sciences partners with you at any stage in the process, whether your program is in the Chemistry, Manufacturing, and Controls (CMC) stage or applying Good Manufacturing Practices (GMP) as standards and procedures. Our experience spans product development phases I, II, and III through commercialization. Achieve compliance with various guidelines and requirements, such as FDA, ICH, EP and USP, with our analytical testing services conducted in state-of-the-art facilities across our U.S.-based laboratory network.
To streamline the client experience, we offer a secure data portal via a web-based delivery system to access methods, specifications, stability protocols and reports, final reports, sample receipt data, instrument raw data, and more. In fact, the information available is thorough and robust so that most, if not all, aspects of a data audit are available to conduct it remotely guided by our Quality Assurance personnel.
Below you can find a brief overview of our services to get a sense of what we offer. If you do not find what you are looking for, do not hesitate to reach out for a more comprehensive understanding.
Raw Materials
In-Process Formulation
Finished Drug and/or Medical Device Products
Drug-Excipient Compatibility Studies
Differential Scanning Calorimetry (DSC)
Powder X-ray Diffraction (XRD)
Polarized Light Microscopy (PLM)
Particle Size Analysis (LLS)
Forced-Degradation Studies
Solubility Determination (aqueous/solvents)
Texture Analysis
Bulk Powder Characterization
Cleaning Validation
Compendial Verification
Stability of Standard and Sample Solution
Custom protocols are developed using the following parameters:
Accuracy (at limit)
Specificity
Limit of Detection / Limit of Quantization
Stability of Standard and Sample
Custom protocols are developed using the following parameters:
Instrument / Method Precision
Accuracy
Linearity / Range
Specificity – Matrix Components
Specificity – Forced Degradation Studies
Method Robustness / Ruggedness
Limit of Detection / Limit of Quantization
Intermediate Precision
Ready to Get Started? Connect with our team to discuss your needs.
