Pharmaceutical
RJ Lee Group scientists use rationalized analytical methods coupled with new and existing technologies to provide solutions that span the entire product life cycle.
We use standard and directed methods in support of regulatory compliance and quality control.
Linxian Wu, Ph.D. Industry Contact
Our scientists are experts in various disciplines from foreign matter isolation and identification in raw materials to evaluation of content uniformity in finished products. We work closely with our clients to understand the issues surrounding each situation. Our established quality system allows us to use and/or develop validated protocols and execute them in a cGMP level environment. We are also an FDA-registered laboratory.
Right Method/Right Solution
Our process begins by defining the problem, pinpointing the
information and understanding how it relates to our clients’
situation. From there, we identify a course of action so that we
can match the problem to a solution. Our examinations in support of
regulatory compliance and quality control encompass standard
procedures developed internally as well as regulatory methods.
These may be used alone or in conjunction with each other to
provide the most comprehensive remedy and/or an entirely customized
protocol. While the product itself is undergoing scrutiny, the
environment in which it is produced is also a critical factor. Our
environmental experts also work with our clients to ensure the
production environment is free of contaminants.
We use appropriate analytical instrumentation to address each
problem such as x-ray diffraction techniques for lot-to-lot
equivalency, high resolution electron microscopy for particle
morphology studies, energy dispersive mapping for elemental imaging
of finished products and molecular spectroscopy for identification
of organic materials. Our scientific expertise allows us to go
beyond the delivery of data and facilitate the development of
solutions.
- USP Testing
- CAPA Investigations
- OOS Investigations
- Content Uniformity Investigations
- Contamination Identification
- Source Determination
- Surface Defect Analysis
- Root Cause Analysis
- Particle Morphology Evaluation
- Particle Size Analysis
Up to the Challenge
Our experts have been called upon to investigate manufacturing inconsistencies, identify and source foreign material, participate in OOS investigations, and examine surface material abnormalities. At RJ Lee Group, no matter what the challenge, we manage the solution.
