Services
Senior scientific judgment, applied where your program needs it.
Consulting
- 01
Small-molecule bioanalysis
End-to-end support for exploratory and regulated studies: method strategy, LC-MS/MS development and validation, sample-analysis oversight, and report review. Method experience spans small molecules, peptides, proteins, and polymers.
- 02
Nonclinical DMPK
In vivo and in vitro study design, protocol development, data analysis, and interpretation for metabolite profiling, metabolite identification, DDI, and PK studies that support go/no-go decisions.
- 03
Regulatory strategy
Study design and submission planning for IND and NDA, including preparation for regulatory interactions.
- 04
Outsourcing and CRO oversight
CRO selection, study placement, and oversight across multiple CROs at once, including assay troubleshooting and root-cause investigation, drawing on 10+ years on each side of the sponsor–CRO relationship.
Specialized services
- 05
PK and TK analysis and reporting
Noncompartmental analysis (NCA) of pharmacokinetic (PK) and toxicokinetic (TK) data, including exposure, dose proportionality, accumulation, and sex comparisons, with audit-ready PK/TK reports and report sections for nonclinical and clinical studies.
- 06
Technical writing
SOPs, protocols, study reports, and submission documents, plus automated PK and bioanalysis reporting.
- 07
Laboratory operations
Set up new bioanalysis and DMPK laboratories, or streamline and automate the routine workflows in existing ones.
- 08
Training and coaching
Hands-on HPLC and LC-MS/MS training, method-development and troubleshooting coaching, and instruction in writing and editing English scientific reports.
Areas of focus
Approach
A clear path from question to decision.
Engagements are scoped to your stage, whether that is a single report review or ongoing program support across CRO partners.
- 01
Review
Start with your data, reports, and timelines to define the real question.
- 02
Design
Study plans, decision trees, and CRO specifications fit to your stage and budget.
- 03
Oversee
Method, sample-analysis, and report review alongside your CRO partners.
- 04
Decide
Decision-ready interpretation and documentation built for regulatory submission.