Experience Experic Analytical Services
Experic’s analytical services provide powerful support at every phase of pharmaceutical development and manufacturing.
Our experienced analytical team empowers your ability to make informed, critical decisions about your drug product(s) development process(es) and meet your regulatory requirements.
With a team of experienced scientists and a robust toolbox of analytical techniques, Experic can support the total life cycle of your oral solid dose and/or inhalation pharmaceutical products. Our laboratory staff provides comprehensive analytical solutions to support the entire spectrum of development and manufacturing:
- Formulation and process development activities
- Development and validation of analytical techniques
- Analysis of in-process samples
- GMP release at clinical-scale and commercial products
Based on a consultation with you and your team, Experic project specialists will recommend phase-appropriate analyses to support patient safety, develop efficient manufacturing processes, and prepare CMC data for examination by regulatory authorities.
Our laboratory includes 3,800 square feet of GMP analytical lab space and a team of seasoned laboratory scientists. It is designed for a broad range of analytical techniques and outfitted with equipment to support the development and manufacture of a variety of drug delivery modalities, including dry powder inhaled (DPI) therapeutics.
The laboratory’s more extended capabilities include the analysis of products requiring special environmental controls for storage, as well as physiochemically hygroscopic, light-sensitive materials and controlled substances. Laboratory operations comply with 21 CFR Part 21121 CFR Part 11, EudraLex Volume 4, and ICH Q10.
Our suite of Analytical Services
- Technology transfer
- Method feasibility, development, and validation
- Release testing of raw materials, API, and finished products
- Stability assessments aligned with ICH Q1A(R2) guidance for long-term, intermediate, and accelerated conditions
- Compendial testing (USP, Ph. Eur., BP, JP)
