Pharmaceutical Services and Medical Device Development

RJ Lee Group laboratories are ISO-compliant and FDA-registered with a well-established pharmaceutical quality system. Our pharmaceutical services experts use and develop validated protocols and execute them in a cGMP-level environment to investigate your problem and provide swift resolution. In addition to investigating your particulate matter, we provide pharmaceutical failure analysis personal database repositories to aid in future contaminant investigations. 

Our Laboratory Capabilities

To help our clients save time and mitigate risk, we offer diverse pharmaceutical services including root cause analysis, contamination identification, foreign particulate analysis, particle size analysis, morphology determination, industrial hygiene and regulatory assistance with CAPA investigations and OOS investigations.

We help you to deliver products to market faster by helping product engineers understand the microstructure of their chosen materials and responding to challenges within the marketplace. Our experts provide critical insight and assistance during the design and manufacturing phases for medical devices, including work with proprietary materials and processes.

Our expert services include:

• Raw materials specification, selection, consistency, and validation
• Quality control testing
• Device cleanliness assessments and impurity identification
• Wear debris studies
• Environmental health and safety issues
• Technical support for FDA submittals and regulatory compliance

Making Durable Products

RJ Lee group continues to support our clients well into a products life cycle by studying the cause of deterioration, corrosion, defects, or failures. By studying the quantity, size, chemical composition, and morphology of particles released as wear debris from implants, we help clients to continually improve material selection and design.

In the event that any of these factors result in an adverse biological response that could affect the long-term survival of the device and end user complaints, we offer root cause investigation and litigation support services. Whether you are developing next generation stents, evaluating surgical instruments, or assessing the wear of total intervertebral disc (IVD) prostheses, rely on us for materials expertise. 

Tap into the vast resources and expertise offered by RJ Lee group to streamline product development, ensure regulatory compliance, augment quality control programs, and simplify manufacturing. Connect with our team of materials experts and together we can take on the challenge of driving innovation while maintaining safety and compliance.