What We Offer 

Explore the core analytical disciplines that power MedPharm’s development and manufacturing programs: 

🔬 Analytical & Bioanalytical Method Development 

We develop robust, validated methods tailored to the specific characteristics of topical and transdermal formulations. Our expertise includes: 

• Assay and impurity profiling 

• Preservative content and degradation studies 

• Microbial limits and antimicrobial effectiveness  

• Skin and tissue extraction techniques 

• Method validation in accordance with ICH Q2(R1) and global regulatory guidance 

📦 Stability Studies 

Our stability programs predict and monitor how your product performs over time under real-world and accelerated conditions. Our ICH-compliant studies include: 

• Long-term, accelerated, and stress condition studies 

• Evaluations of photostability and humidity impact 

• Storage analyses in various packaging configurations 

• Integrated analytical testing and trend reporting 

• Full support for CTD submissions and shelf-life claims 

🧬 Research Bioanalysis 

Gain deeper insight into drug delivery, absorption, and distribution using advanced bioanalytical techniques specific to skin and tissue matrices. Our services encompass: 

• API quantification in skin layers, nails, and mucosal tissue 

• Support for IVPT, IVRT, and protein binding studies 

• Customized methods for preclinical and clinical sample analysis 

• High-sensitivity LC/MS/MS and HPLC-based assays 

Why MedPharm?  

• Specialized Expertise in Dermatological Products 

Tailored analytical methods for semisolid, liquid, and transdermal dosage forms. 

• Integrated with Formulation & Manufacturing 

Seamless coordination across R&D, clinical supply, and commercial scale-up. 

• Regulatory Readiness 

Data packages are built to meet FDA, EMA, and MHRA expectations. 

• Validated Facilities & Technology 

Equipped for GMP and GLP-compliant analysis, stability testing, and method development. 

A Smarter Approach to Testing 

MedPharm’s analytical services provide more than just compliance—they offer confidence. Our scientists work as part of your extended team to solve problems, generate high-quality data, and ensure your product meets the highest standards at every stage. 

Let’s test, analyze, and advance—together. 

Analytical & Bioanalytical Method Development

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  

• [Learn More About Stability Testing & Quality Control →] 

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  

• [Learn More About Bioequivalence & Research Bioanalysis →] 

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  

• [Learn More About Regulatory & Compliance Expertise →] 

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  

• [Learn More About Impurity Profiling & Risk Assessment →] 

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  

• [Learn More About Regulatory Documentation & Submission Support →] 

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.  

Contact us today to learn how our Analytical and Bioanalytical Method Development services can support your pharmaceutical development and regulatory approval goals! 

Stability Testing

Ensuring Product Efficacy and Safety Over Its Lifecycle 

At MedPharm, we recognize that stability testing is crucial for demonstrating the shelf life, efficacy, and safety of pharmaceutical products. Our ICH-compliant stability programs ensure that your formulations maintain their physical, chemical, and microbiological integrity over time. This not only meets regulatory requirements but also supports successful product approvals. 

Comprehensive Stability Testing Services 

Our stability studies assess how temperature, humidity, light, and packaging conditions impact drug products, helping to: 

✔ Determine product shelf life and expiration dating 

✔ Optimize formulation stability during development 

✔ Support regulatory submissions with robust data 

✔ Ensure consistent quality throughout storage and distribution   

1. Long-Term Stability Studies 

Conducted under ICH Q1A(R2) guidelines 

Monitors product integrity over months to years 

Required for regulatory submissions and commercial approvals   

2. Accelerated Stability Studies 

Designed to predict long-term stability under elevated temperature and humidity conditions 

Rapidly assesses potential degradation pathways 

Helps optimize packaging and storage conditions  

3. Stress Testing (Forced Degradation Studies) 

Exposes products to extreme environmental conditions (heat, humidity, oxidation, photolysis) 

Identifies degradation pathways and establishes stability-indicating analytical methods 

Supports regulatory submissions by demonstrating formulation robustness   

4. Photostability Testing 

Evaluates the effect of light exposure on product stability 

Ensures drug formulations remain stable under real-world lighting conditions   

5. Freeze-Thaw Stability Studies 

Assesses product integrity after multiple freeze-thaw cycles 

Critical for biologics, emulsions, and temperature-sensitive formulations  

  Advanced Stability Storage Capabilities 

MedPharm’s state-of-the-art stability chambers are fully qualified and monitored, offering: 

📌 ICH-compliant storage conditions: 

25°C ± 2°C / 60% RH ± 5% RH (Long-term) 

40°C ± 2°C / 75% RH ± 5% RH (Accelerated) 

5°C ± 3°C, -20°C ± 5°C, -70°C ± 15°C (Cold storage) 

📌 Customized storage solutions for unique formulations 

📌 Real-time monitoring and automated alerts for temperature excursions 

  Why Partner with MedPharm for Stability Testing? 

✅ Regulatory Excellence – ICH, FDA, EMA, and GMP-compliant studies 

✅ Comprehensive Data Packages – Supporting IND, NDA, ANDA, and other global filings 

✅ Advanced Analytical Support – Integrated with method development and validation 

✅ Flexible Study Designs – Tailored to meet specific formulation needs 

 Ensure the Longevity and Success of Your Product 

 With a strong history in stability testing, MedPharm is your reliable partner for ensuring product quality from development to commercialization. 

Research Bioanalysis

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 

🔹 [Learn More About Analytical & Bioanalytical Method Development →] 

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 

🔹 [Learn More About Bioequivalence Testing →] 

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 

🔹 [Learn More About Impurity Profiling & Risk Assessment →] 

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 

🔹 [Learn More About In Vitro Testing & Stability Studies →] 

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 

🔹 [Learn More About Regulatory and Compliance Expertise →] 

Why Choose MedPharm for Research Bioanalysis? 

• Industry-leading expertise in bioanalytical testing and drug development 

• Regulatory-Driven Analytical Method Development for IND, NDA, and ANDA filings 

• Comprehensive Stability and Impurity Profiling for drug formulation optimization 

• Seamless Integration with pharmacokinetic and bioequivalence studies 

• GMP and GLP-Certified Laboratories supporting clinical and commercial drug development 

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.  

Contact us today to learn how our Research Bioanalysis services can support your pharmaceutical development and regulatory approval goals!