Bioanalytical excellence that you can trust, on-time, every time
Bioanalytical Services
You can be sure of the best scientific excellence, industry leading on-time delivery, and unrivalled customer service
Let our experts solve your problems
With our unparalleled expertise and customized solutions, we can help you elevate your drug development process to the next level. Whether you need bioanalysis or pharmacokinetic analysis, we have the right team and the right tools. Don’t settle for less, choose Royalmount Laboratories as your partner for your drug development programs.
Small Molecule Bioanalysis
- Method development from first principles
- Transfer Sponsors’ methods directly
- Modification of Sponsor/ literature methods
- Full validation
- Partial / cross-validation
- ICH M10, EMA and FDA validation guidelines
- Selectivity, accuracy and precision, recovery and the various stability evaluations
- Hemolysis effect, lipemic effect, metabolite interference
Large Molecule Bioanalysis
- ELISA
- Biomarkers
- Hybridization-ELISA
- Luminex
- RT-qPCR
Platforms
INSTRUMENTATION AND LIMS
- 2 x API 6500+ QTRAP
- 2 x API 6500+
- 8 x API 5000
- 2 x Multimode spectrophotometer readers
- 1 x Luminex
- 2 x Hamilton Star Robots
- Watson LIMS
Expertise
- Parent compounds
- Metabolites
- Endogenous compounds
- Co-administered drugs
- Small molecules
- Large molecules
- Proteins
- Peptides
- Dried Blood Spot (DBS)
- Microsampling
Matrices Analyzed
- Aorta
- Bone marrow
- Brain
- Cerebrospinal fluid (CSF)
- Eye tissues
- Heart
- Kidney
- Liver
- Lung
- Plasma
- Serum
- Skin
- Spleen
- Whole blood
Typical Timelines
- New program lead-in time: 10 days
- Sample analysis lead-in time: 5 days
- Method transfer: 10 days
- Method optimization: 10 days
- Full method development: 15 days
- Full validation: 15 days
- QC’d data: 3 days
- QA’d data: 5 days
By the Numbers
- Number of years in operation: 39
- Number of staff: >45
- Number of R&D scientists: 6
- Number of PK Scientists: 4
- Number of LC-MS/MS: 12
- Number of robotic liquid handlers: 2
- Number of -70C / -20C / refrigerated storage units: 10
- Number of samples analyzed each year: 450,000
- Number of methods developed and validated each month: 6
- Number of molecules analyzed: >450
- Number of non-proprietary validated methods: >250
- Number of different types of matrices analyzed: 14
- Bioanalytical run acceptance rate: >98.5%
- On-time delivery: >99%
- Incurred sample reanalysis failure rate: 0%
- Number of regulatory audits: 9
- Number of FDA 483s: 0
Customer Service
- Responsiveness – reply to all messages within 1 business day
- Openness – complete transparency
- Teamwork – partnerships with Sponsors
- Flexibility – accommodate any requests
- Communication – regular status updates
We have had the pleasure of working with Royalmount Laboratories on several projects over the past few years. From developing challenging bioanalytical methods to supporting nonclinical programs, we have been continually impressed by the Royalmount Laboratories team’s work
ASSAY LIST
We currently have the following validated assays available.
View assay list