Your Trusted Partner in Pharmaceutical Testing and Compliance
At LGM Pharma, we support pharmacies and pharmaceutical manufacturers with cGMP-compliant analytical testing services designed to ensure product quality, patient safety, and regulatory compliance.
LGM Pharma offers analytical testing on a contract basis with our FDA-inspected, ISO 9001 certified testing facility in Irvine, CA. With industry-leading responsiveness and deep regulatory expertise, we offer fast, reliable testing that pharmacies and manufacturers trust.
We tailor our services based on the unique regulatory requirements of various segments of the pharmaceutical industry:
- 503A compounding pharmacies
- 503B outsourcing facilities
- Hospital pharmacies
- Pharmaceutical manufacturers
- Generic and branded pharmaceutical developers
- API and excipient suppliers
Core Analytical Testing Capabilities
We offer a comprehensive suite of testing services, including:
Chemical and Physical Testing
- Elemental impurities (USP <232>/<233> via ICP-MS)
- Residual solvents (USP <467>)
- Assay and impurity profiling
- Stability testing (ICH-compliant, up to 180 days)
- Physicochemical tests (e.g., ID, TOC, moisture/LOD, wet chemistry)
Microbiological Testing:
- Microbial limits (USP <61>/<62>)
- Antimicrobial effectiveness (USP <51>)
- Bacterial endotoxin (USP <85>)
- Sterility studies (USP <71>)
- Rapid sterility, 5-day turnaround
Method Development & Validation
- Custom method development and validation
- Stability-indicating methods
- Cleaning validation
- Water system validation
Specialized Support for Compounding and Outsourcing Facilities
LGM Pharma understands the complex regulatory landscape and technical needs of 503A and 503B pharmacies, with specialty support including:
- USP <795>, <797>, and <800> compliance
- Batch release testing for compounded preparations
- Method verification and validation for custom formulations
- Testing for active ingredient concentration, content uniformity (USP <905>), sterility (USP <71>), and endotoxins (USP <85>)
Your Full-Service Pharmaceutical Partner
As part of our vertically integrated service model, we also offer:
- API sourcing from a global network of pre-qualified, FDA-inspected manufacturers
- U.S.-based drug product CDMO services for oral solids, topicals, suppositories, and solutions/suspensions
For compounding pharmacies and virtual drug development companies, outsourcing analytical services is an absolute necessity. In all cases, it’s essential to find a provider that meets your needs and your expectations for prompt turnaround, timely communication, and most of all, excellent quality.