LAB TESTING AREAS
Pharmaceutical Services and Medical Device Development
Having the myriad of legal, financial, regulatory, and competitive hurdles required to develop a successful medical devices and pharmaceutical products requires innovative thinking across a diverse range of expertise and disciplines.
RJ Lee group gives you the power to quickly expand your research and development team by tapping into decades of scientific experience backed by expansive and up to date scientific technology. From analytical testing to legal advice, RJ Lee group gives you a competitive edge.
A History of Expertise and Innovation
RJ Lee Group has assessed environmental issues since the early 1980s when our Energy Technology Consultants (ETC) pioneered the recognition of specific air quality patterns. We developed a cutting-edge technique for identifying, measuring, and characterizing particles in the air using computer-controlled scanning electron microscopy (CCSEM).
RJ Lee Group has worked with clients in various industries, including the U.S. Environmental Protection Agency (EPA), to assess and provide solutions for environmental factors that could affect our health. Our services have grown over the years, from setting controls for unbound nanoparticles (UNP) to designing and building test chambers to simulate specific environmental conditions.
Today we offer our expertise for our clients’ environmental and compliance concerns and perform rigorous assessment and management of potential environmental risks.
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.
RJ Lee Group & Medical Device Development
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.
Laboratory Manager of Analytical Services & Senior Chemist
Steve coordinates and provides technical oversight to a staff of highly trained technical specialists in materials and particle characterization. His focus includes analytical method development and implementation of appropriate laboratory methodologies for a wide range of projects, including consulting services to assess project needs and directing appropriate implementation of laboratory testing services for environmental and materials applications.
Develop Your Next Product with RJ Lee Group
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.