Proven Methods. Reliable Processes. Confident Submissions.  

At MedPharm, validation is not just a milestone; it’s a fundamental mindset. Whether you are preparing for regulatory submission, clinical trial supply, or a commercial launch, our Validation Studies ensure that your methods and processes are reproducible, reliable, and ready for inspection.   

As a specialist CDMO focused on topical and transdermal drug products, we provide tailored validation solutions that meet the highest scientific and regulatory standards.   

Our Validation Approach

Our integrated teams of analytical chemists, formulation scientists, and manufacturing experts collaborate to design, execute, and document validation studies that comply with current ICH, FDA, and EMA expectations. MedPharm’s approach ensures that:  

• Analytical methods are accurate, precise, specific, and robust.  

• Manufacturing processes are consistent, scalable, and controlled.  

• Documentation is thorough, audit-ready, and regulatory-compliant.  

• Risks are identified early and mitigated before impacting timelines. 

We provide the data and confidence you need to progress—whether you are entering clinical trials or preparing a commercial NDA/MAA submission.  

Build Validation into Every Step

Validation should enhance your program, not slow it down. Partner with MedPharm to incorporate quality, compliance, and confidence throughout your development lifecycle.   

Explore Our Validation Capabilities

MedPharm offers comprehensive validation services customized to each product’s stage of development and regulatory path. Click below to explore each area in detail: