Bioanalytical Services

A key drug development challenge is understanding how a compound moves across different systems.

These systems include in vitro models and biological matrices. Bioanalytical studies quantify drug levels across a wide range of sample types.

MedPharm supports programs from in vitro release and permeation testing through in vivo biological sample analysis.

Our Services:

Bioanalytical methods are developed in consultation with sponsors to ensure they meet the rigorous standards required for each individual program. Instrumentation is matched to the study design and the molecules being tested, and limits of quantitation can reach as low as pg/mL levels.

MedPharm provides many bioanalytical services designed to meet the needs of customers during various stages of drug development, including:

Bioanalytical Method Development

Bioanalytical Method Qualification

Bioanalytical Method Validation

Study Sample Analysis

Scientist performing bioanalytical services using LC-MS/MS instrumentation in a pharmaceutical laboratory. Scientist performing in vitro release and permeation testing (IVRT/IVPT) using diffusion cells in a pharmaceutical laboratory

Pharmacokinetics & Drug Movement Analysis

Assessment of early-stage samples to evaluate how a drug moves through animal models, providing critical insight into compound behaviour at key stages of development.
Calculation and evaluation of drug concentrations across a wide range of study types, delivering accurate pharmacokinetic profiles to guide development decisions.
Expert PK support across diverse study designs, helping sponsors understand drug absorption, distribution, and clearance from early discovery through to preclinical studies.

Regulatory Guidance

All bioanalytical work is conducted in accordance with ICH M10 guidance on Bioanalytical Method Validation and Study Sample Analysis, ensuring a rigorous and consistent regulatory framework.
The ICH M10 framework underpins all quantitation activities, supporting the generation of high-quality, audit-ready data suitable for regulatory submissions.
Our team applies this guidance across method development, validation, and sample analysis — giving sponsors confidence that their data will meet the standards required by global regulatory authorities.

Our Bioanalytical Instrumentation:

Our team uses advanced analytical platforms including HPLC, UHPLC, and LC-MS/MS to generate high-quality, reliable bioanalytical data. In addition to these systems, our laboratory is equipped with a Hamilton Vantage liquid handler to support automated sample preparation.

HPLC/UHPLC	LC–MS/MS
Shimadzu Prominence	Sciex Triple Quad 6500+ System
Shimadzu Nexera	Sciex Triple Quad 5500+ System
Shimadzu Integrated LC-2050C	Sciex Triple Quad 5500 System
Includes both Fluorescence and UV detection	Waters Triple Quad TQ-XS System
	Shimadzu Triple Quad 8040 System

Skin Metabolism

Human skin contains many of the enzymes capable of metabolism, although at much lower levels compared to the liver. There are several ways to assess metabolism in vitro. Keratinocytes are likely the major contributor to metabolism in the skin, and these cells can be used either individually or in a reconstructed human epidermis (RHE).

A more holistic approach can be taken by using freshly obtained human skin and monitoring the metabolic pathway. These are all studies that MedPharm’s bioanalytical team can support.

Applications