Ensuring Precision, Reliability, and Regulatory Compliance  

At MedPharm, our Analytical and Bioanalytical Method Development services provide essential testing solutions to ensure the accuracy, stability, and regulatory compliance of topical and transdermal drug products. By leveraging advanced analytical instrumentation, cutting-edge methodologies, and validation strategies aligned with regulatory standards, we generate high-quality, reproducible data to support formulation development, bioequivalence studies, and global regulatory submissions.   

With expertise in method development, validation, impurity profiling, stability assessment, and bioanalytical testing, MedPharm ensures that pharmaceutical companies receive robust, regulatory-compliant analytical support from early-stage research through to commercial manufacturing.    

Key Components of Analytical and Bioanalytical Method Development  

Custom Analytical Method Development   

• Development of analytical methods for drug identity, potency, and impurity quantification   

• Optimization of HPLC, LC-MS/MS, GC-MS, and other advanced analytical techniques   

• Assay development for dissolution, viscosity, pH, and rheological properties   

• Tailored method design for complex formulations, including creams, gels, foams, and transdermal patches   

Bioanalytical Method Development for Drug Absorption and Pharmacokinetics   

• Quantification of drug levels in biological matrices (plasma, tissue, skin layers, and mucosa)   

• Assessment of absorption, metabolism, and systemic distribution of topical drugs   

• Support for bioequivalence studies and 505(b)(2) regulatory pathways   

• Evaluation of penetration enhancers and formulation modifications for improved bioavailability   

Method Validation for Regulatory Compliance   

• ICH-compliant validation of analytical and bioanalytical methods   

• Validation parameters include accuracy, precision, linearity, robustness, and specificity   

• Batch-to-batch reproducibility and process control validation   

• Comprehensive validation reports supporting IND, NDA, ANDA, and global filings   

Impurity Profiling and Stability Testing   

• Identification and quantification of degradation products and residual solvents   

• Forced degradation studies to assess formulation robustness   

• ICH Q1A-compliant stability testing for product shelf-life determination   

• Extractables and leachables testing to ensure formulation safety   

Regulatory-Driven Data Integrity and Compliance   

• GMP and GLP-compliant method development and validation   

• CMC (Chemistry, Manufacturing & Controls) documentation preparation   

• Data integrity compliance with FDA 21 CFR Part 11 and global regulatory guidelines   

• Comprehensive analytical support for regulatory audits and inspections   

Why Choose MedPharm for Analytical and Bioanalytical Method Development?  

• Industry-Leading Expertise in Method Development and Validation   

• Regulatory-Compliant Analytical Support for IND, NDA, and ANDA Filings   

• Comprehensive Stability and Bioequivalence Testing for Market Approval   

• Seamless Integration with Formulation Development and Process Scale-Up   

• GMP and GLP-Certified Laboratories Supporting Clinical and Commercial Drug Development 

Ensure Analytical Precision and Regulatory Compliance with MedPharm’s Expertise 

With state-of-the-art analytical instrumentation, regulatory-driven validation, and expert bioanalytical testing, MedPharm ensures that your topical and transdermal drug formulations achieve optimal performance, compliance, and commercial success.