Precision Analytical Testing for Drug Development and Bioequivalence Studies

MedPharm’s Research Bioanalysis services provide essential analytical insights to support preclinical, clinical, and regulatory submissions for topical and transdermal drug formulations. By utilizing state-of-the-art bioanalytical techniques, we ensure that precise, reliable, and regulatory-compliant data support pharmacokinetic (PK) and bioequivalence (BE) studies.

Our comprehensive bioanalytical capabilities—including drug quantification, impurity profiling, and stability assessment—help pharmaceutical companies optimize drug formulations, support IND/NDA/ANDA filings, and accelerate time to market.

Key Components of Research Bioanalysis

Bioanalytical Method Development and Validation 

• Development and validation of bioanalytical assays for regulatory compliance
• High-performance liquid chromatography (HPLC) and LC-MS/MS for drug quantification
• Assessment of drug stability, metabolism, and degradation profiles
• ICH-compliant analytical method validation for NDA, ANDA, and IND filings

Pharmacokinetic (PK) and Bioequivalence (BE) Studies 

• Quantification of drug absorption, distribution, metabolism, and excretion (ADME)
• Support for bioequivalence studies in generic and 505(b)(2) regulatory pathways
• Tissue and plasma drug concentration analysis for PK modeling
• Comparative analysis of formulation performance in vivo and in vitro

Impurity Profiling and Residual Solvent Analysis 

• Identification and quantification of potential formulation impurities
• Detection of residual solvents, degradation products, and trace contaminants
• Regulatory-compliant extractables and leachables testing
• Forced degradation studies to evaluate formulation robustness

Drug Stability and In Vitro Release Testing 

• ICH-compliant stability studies to support long-term drug viability
• In-vitro release testing (IVRT) to assess drug dissolution and diffusion rates
• In-vitro permeation testing (IVPT) for bioavailability and skin penetration analysis
• Customized stability programs for IND/NDA/ANDA submissions

Regulatory Compliance and Data Integrity 

• GMP and GLP-compliant bioanalytical testing aligned with FDA and EMA regulations
• CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory filings
• Data integrity compliance with FDA 21 CFR Part 11 and ICH guidelines
• Comprehensive regulatory support for method validation and submission readiness

Advance Your Drug Development with MedPharm’s Research Bioanalysis Expertise

With scientifically guided bioanalytical testing, state-of-the-art instrumentation, and regulatory-driven validation, MedPharm ensures that topical and transdermal drug formulations achieve optimal stability, efficacy, and regulatory success.